Trial Outcomes & Findings for A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH (NCT NCT02264639)
NCT ID: NCT02264639
Last Updated: 2021-01-08
Results Overview
TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
From single dose of study drug (Day 1) up to 30 days
Results posted on
2021-01-08
Participant Flow
Paroxysmal nocturnal hemoglobinuria (PNH) subjects who were still anemic during treatment with eculizumab (Soliris®) were enrolled in this Phase 1, open-label, single- and multiple-ascending dose study to receive treatment with pegcetacoplan (APL-2) as an add-on to standard of care treatment. The study was conducted at 7 sites in the United States.
Subjects could participate in more than 1 cohort. Overall, 9 unique subjects were evaluated in 4 cohorts, with some subjects participating in \>1 cohort. Single-dose phase: 4 unique subjects evaluated (2 each in Cohorts 1 and 2). Multiple-dose phase: 8 unique subjects evaluated, comprising 3 subjects who also participated in single-dose phase (1 in Cohort 1; 2 in Cohort 2) plus a further 5 unique subjects. Each cohort included a 30-day screening phase prior to treatment with pegcetacoplan.
Participant milestones
| Measure |
Cohort 1 Single- and Multiple-dose Phase
Cohort 1 single-dose phase: Subjects received a single subcutaneous (SC) dose of 25 milligrams (mg) pegcetacoplan on Day 1.
Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single- and Multiple-dose Phase
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohorts 3 and 4 Multiple-dose Phase
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohort 4 Multiple-dose Phase
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
1
|
4
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 Single- and Multiple-dose Phase
Cohort 1 single-dose phase: Subjects received a single subcutaneous (SC) dose of 25 milligrams (mg) pegcetacoplan on Day 1.
Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single- and Multiple-dose Phase
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohorts 3 and 4 Multiple-dose Phase
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohort 4 Multiple-dose Phase
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|---|
|
Overall Study
Death (after completing single-dose phase)
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by subject (during multiple-dose phase)
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Pregnancy (during multiple-dose phase)
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Major Intercurrent Illness (during multiple-dose phase)
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
Baseline characteristics by cohort
| Measure |
Cohort 1 Single- and Multiple-dose Phase
n=2 Participants
Cohort 1 single-dose phase: Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
Cohort 1 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 5 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single- and Multiple-dose Phase
n=1 Participants
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
|
Cohort 2 Single-dose Phase, Then Cohorts 2, 3, and 4 Multiple-dose Phase
n=1 Participants
Cohort 2 single-dose phase: Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
Cohort 2 multiple-dose phase: Following a waiting period of at least 28 days after single dosing, subjects received 30 mg/day SC dose of pegcetacoplan for 28 days (from Day 29 to Day 56).
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohorts 3 and 4 Multiple-dose Phase
n=1 Participants
Cohort 3 multiple-dose phase: Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Cohort 4 Multiple-dose Phase
n=4 Participants
Cohort 4 multiple-dose phase: Subjects received 270 mg/day SC doses of pegcetacoplan for up to 729 days (from Day 1 up to Day 729). The treatment period consisted of the following:
* Part 1: Subjects received daily doses of pegcetacoplan for 28 days.
* Part 2A: On Day 29, subjects who demonstrated clinical benefit from the treatment were automatically entered into Part 2A and continued to receive daily doses of pegcetacoplan until Day 84.
* Part 2B: If there was ongoing evidence of clinical benefit, subjects who completed Part 2A could enter Part 2B and continue to receive daily doses of pegcetacoplan until Day 364.
* Part 2C: If there was ongoing evidence of clinical benefit, subjects who completed Part 2B could enter Part 2C and continue to receive daily doses of pegcetacoplan until Day 729.
After Day 28 (Part 1), individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
9 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From single dose of study drug (Day 1) up to 30 daysPopulation: The safety population included all enrolled subjects who received at least 1 dose of study drug.
TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.03) based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Outcome measures
| Measure |
Cohort 1 Single-dose Phase
n=2 Participants
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
n=2 Participants
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 3 Multiple-dose Phase
Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Any TEAE
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
TEAE at least possibly related to study drug
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Serious TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
TEAE leading to study drug discontinuation
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
TEAE leading to death
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Maximum severity of all TEAEs: mild
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Maximum severity of all TEAEs: moderate
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Including by Severity, During Single-dose Phase
Maximum severity of all TEAEs: severe
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug up to 30 days after last dose of study drug (Cohorts 1-3: up to 58 days; Cohort 4: up to 759 days).Population: The safety population included all enrolled subjects who received at least 1 dose of study drug.
TEAEs were defined as AEs that developed or worsened after first dose of study drug (Day 1), and up to 30 days after last dose of study drug. The Investigator assessed AEs for severity and relatedness to study drug. AEs were graded according to CTCAE, v4.03 based on: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death related to AE.
Outcome measures
| Measure |
Cohort 1 Single-dose Phase
n=1 Participants
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
n=2 Participants
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 3 Multiple-dose Phase
n=2 Participants
Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
n=6 Participants
Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Any TEAE
|
1 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
TEAE at least possibly related to study drug
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
TEAE leading to study drug discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Maximum severity of all TEAEs: mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Maximum severity of all TEAEs: moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Maximum severity of all TEAEs: severe
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With TEAEs, Including by Severity, During Multiple-dose Phase
Maximum severity of all TEAEs: life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Blood samples for PK assessment were collected pre-dose and 4 hours post dose on Day 1 and pre-dose (trough) on Day 2 and up to Day 785.Population: The PK population was defined as all subjects in the safety population who had at least 1 PK sample drawn with a measurable serum concentration. Results were reported for Cohort 4 only. Due to the small sample size in Cohorts 1 through 3, summaries for continuous data using descriptive statistics were not performed.
Assessment of AUC0-t of pegcetacoplan over the multiple dosing phase, estimated using a non-compartmental approach and calculated by the linear-log trapezoidal method. Pegcetacoplan pharmacokinetic (PK) parameters were summarized for Cohort 4 only.
Outcome measures
| Measure |
Cohort 1 Single-dose Phase
n=6 Participants
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 3 Multiple-dose Phase
Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) From Time 0 to the Last Measurable Concentration (AUC0-t) Over the Multiple Dosing Phase for Cohort 4
|
6,500,000 micrograms*hour/milliliter (μg*hour/mL)
Standard Deviation 3,990,000
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Blood samples for PK assessment were collected pre-dose and 4 hours post dose on Day 1 and pre-dose (trough) on Day 2 and up to Day 785.Population: The PK population was defined as all subjects in the safety population who had at least 1 PK sample drawn with a measurable serum concentration. Results were reported for Cohort 4 only. Due to the small sample size in Cohorts 1 through 3, summaries for continuous data using descriptive statistics were not performed.
Assessment of Ctrough,max of pegcetacoplan over the multiple dosing phase, estimated using a non-compartmental approach. Pegcetacoplan PK parameters were summarized for Cohort 4 only. Ctrough,max was calculated for both 270 mg/day and 360 mg/day where subjects received both doses. Note: 1 subject in Cohort 4 who was receiving 360 mg/day was granted Sponsor and institutional review board approval to increase the dose further to the equivalent of 440 mg/day and Ctrough,max is also reported for this dose.
Outcome measures
| Measure |
Cohort 1 Single-dose Phase
n=6 Participants
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 3 Multiple-dose Phase
Subjects received 180 mg/day SC dose of pegcetacoplan for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
Subjects received 270 mg/day SC dose of pegcetacoplan for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|
|
Maximum Pre-dose Serum Concentration (Ctrough,Max) Over the Multiple Dosing Phase for Cohort 4
270 mg Dose
|
627 μg/mL
Standard Deviation 207
|
—
|
—
|
—
|
|
Maximum Pre-dose Serum Concentration (Ctrough,Max) Over the Multiple Dosing Phase for Cohort 4
360 mg Dose
|
543 μg/mL
Standard Deviation 192
|
—
|
—
|
—
|
|
Maximum Pre-dose Serum Concentration (Ctrough,Max) Over the Multiple Dosing Phase for Cohort 4
440 mg Dose
|
624 μg/mL
Standard Deviation NA
No standard deviation is presented since mean value is derived from a single subject.
|
—
|
—
|
—
|
Adverse Events
Cohort 1 Single-dose Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort 2 Single-dose Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1 Multiple-dose Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 Multiple-dose Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3 Multiple-dose Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 Multiple-dose Phase
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Single-dose Phase
n=2 participants at risk
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
n=2 participants at risk
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 1 Multiple-dose Phase
n=1 participants at risk
Subjects received pegcetacoplan 5 mg/day as SC dose for 28 days (from Day 29 to Day 56).
|
Cohort 2 Multiple-dose Phase
n=2 participants at risk
Subjects received pegcetacoplan 30 mg/day as SC dose for 28 days (from Day 29 to Day 56).
|
Cohort 3 Multiple-dose Phase
n=2 participants at risk
Subjects received pegcetacoplan 180 mg/day as SC dose for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
n=6 participants at risk
Subjects received pegcetacoplan 270 mg/day as SC dose for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
Other adverse events
| Measure |
Cohort 1 Single-dose Phase
n=2 participants at risk
Subjects received a single SC dose of 25 mg pegcetacoplan on Day 1.
|
Cohort 2 Single-dose Phase
n=2 participants at risk
Subjects received a single SC dose of 50 mg pegcetacoplan on Day 1.
|
Cohort 1 Multiple-dose Phase
n=1 participants at risk
Subjects received pegcetacoplan 5 mg/day as SC dose for 28 days (from Day 29 to Day 56).
|
Cohort 2 Multiple-dose Phase
n=2 participants at risk
Subjects received pegcetacoplan 30 mg/day as SC dose for 28 days (from Day 29 to Day 56).
|
Cohort 3 Multiple-dose Phase
n=2 participants at risk
Subjects received pegcetacoplan 180 mg/day as SC dose for 28 days (from Day 1 to Day 28).
|
Cohort 4 Multiple-dose Phase
n=6 participants at risk
Subjects received pegcetacoplan 270 mg/day as SC dose for up to 729 days (from Day 1 up to Day 729).
After Day 28, individual subject dose escalation up to a dose of 360 mg/day could occur in subjects who had a sub-optimal hematological response but acceptable tolerability.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 5 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Fatigue
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 5 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 3 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Serum ferritin increased
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site bruising
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
2/2 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
66.7%
4/6 • Number of events 145 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site induration
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 43 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site erythema
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 19 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
66.7%
4/6 • Number of events 13 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site swelling
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 9 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 8 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site pruritus
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 7 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Infusion-site bruising
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site haemorrhage
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Asthenia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Chills
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Induration
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site discomfort
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site oedema
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Injection-site warmth
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Malaise
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
General disorders
Pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 12 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 9 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 3 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 7 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 7 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 3 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Blood glucose increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Body temperature increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
Vitamin B12 decreased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
83.3%
5/6 • Number of events 11 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
3/6 • Number of events 3 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Eye disorders
Eye irritation
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
33.3%
2/6 • Number of events 4 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
100.0%
1/1 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Nervous system disorders
Diplopia
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
16.7%
1/6 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
50.0%
1/2 • Number of events 1 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/2 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
0.00%
0/6 • TEAE data is reported from first dose of study drug up to 30 days after last dose of study drug (Cohorts 1 and 2, single-dose phase: up to 30 days; Cohorts 1-3, multiple-dose phase: up to 58 days; Cohort 4, multiple-dose phase: up to 759 days).
The safety population included all enrolled subjects who received at least 1 dose of study drug. The 4 cohorts of 12 subjects overall represents 9 unique participants. Subjects could participate in more than 1 cohort. The all-cause mortality table includes the death of 1 subject in Cohort 1, resulting from a serious AE which was not treatment-emergent.
|
Additional Information
Apellis Clinical Trial Information Line
Apellis Pharmaceuticals, Inc.
Phone: 1-833-284-6361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place