Trial Outcomes & Findings for A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis (NCT NCT03133676)
NCT ID: NCT03133676
Last Updated: 2022-12-27
Results Overview
TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Day 1 up to Day 29
Results posted on
2022-12-27
Participant Flow
A total of 60 subjects were randomized to 1 of 7 cohorts to receive KA34 or placebo. In the single-ascending dose (SAD) part, 24 subjects were randomized to receive a single dose of KA34 or placebo in 1 of 4 cohorts. After a thorough review of the Day 29 safety data from the SAD cohorts by the blinded Data Safety Monitoring Board, 36 subjects were randomized in the multiple-ascending dose (MAD) part of the study to receive 4 weekly doses of KA34 or placebo in 1 of 3 cohorts.
Subjects with a diagnosis of osteoarthritis (OA) of the knee as per the clinical and radiographic criteria of the American College of Rheumatology and joint pain with a visual analog scale score of ≥ 40 millimeters (mm) on a 100 mm scale on the index knee, determined by the Investigator at Screening were eligible to join the study.
Participant milestones
| Measure |
Placebo (SAD)
Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single intra-articular (IA) injections of matching placebo in the affected knee and were followed up until Day 29.
|
Cohort 1: KA34 50 µg (SAD)
Subjects received a single IA injection of 50 micrograms (µg) KA34 in the affected knee and were followed up until Day 29.
|
Cohort 2: KA34 100 µg (SAD)
Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 3: KA34 200 µg (SAD)
Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Placebo (MAD)
Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
|
Cohort 5: KA34 100 µg (MAD)
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
6
|
6
|
9
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
6
|
6
|
9
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Placebo (SAD)
n=6 Participants
Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
|
Cohort 1: KA34 50 µg (SAD)
n=3 Participants
Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 2: KA34 100 µg (SAD)
n=3 Participants
Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 3: KA34 200 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Placebo (MAD)
n=9 Participants
Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Total
n=60 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
39 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
33 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
56 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
46 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=10 Participants
|
9 participants
n=115 Participants
|
9 participants
n=24 Participants
|
9 participants
n=42 Participants
|
60 participants
n=42 Participants
|
|
Grade of Osteoarthritis (Kellgren and Lawrence radiological classification system)
Grade 0
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Grade of Osteoarthritis (Kellgren and Lawrence radiological classification system)
Grade 1
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
|
Grade of Osteoarthritis (Kellgren and Lawrence radiological classification system)
Grade 2
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
|
Grade of Osteoarthritis (Kellgren and Lawrence radiological classification system)
Grade 3
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Grade of Osteoarthritis (Kellgren and Lawrence radiological classification system)
Grade 4
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 29Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
TEAEs were collected from time of first administration of IP (Day 1) until 28 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, serious TEAEs (SAE), related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
At least 1 TEAE
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
At least 1 related TEAE
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
At least 1 severe TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
At least 1 severe related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
At least 1 SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
TEAE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs)
TEAE with CTCAE grade >=3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
TEAEs were collected from time of first administration of IP (Day 1) until 30 days after the last administration of IP. The severity of TEAEs was classified by the investigator as mild, moderate or severe and graded using the CTCAE version 5.0. The investigator also assessed relatedness of TEAEs. The number of subjects who experienced any TEAEs, SAEs, related TEAEs and TEAEs with CTCAE Grade ≥ 3 are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Number of Subjects Who Experienced TEAEs
At least 1 TEAE
|
5 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
At least 1 related TEAE
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
At least 1 severe TEAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
At least 1 severe related TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
At least 1 SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
TEAE leading to discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects Who Experienced TEAEs
TEAE with CTCAE grade >=3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in hemoglobin levels for subjects in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in Hemoglobin at Day 8
|
0.08 grams/deciliter (g/dL)
Standard Deviation 0.48
|
-0.12 grams/deciliter (g/dL)
Standard Deviation 0.58
|
0.77 grams/deciliter (g/dL)
Standard Deviation 2.12
|
-0.07 grams/deciliter (g/dL)
Standard Deviation 0.81
|
-0.32 grams/deciliter (g/dL)
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in hemoglobin levels for subjects in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in Hemoglobin at Day 180
|
-0.07 g/dL
Standard Deviation 0.19
|
0.36 g/dL
Standard Deviation 1.21
|
-0.60 g/dL
Standard Deviation 1.01
|
-0.48 g/dL
Standard Deviation 1.29
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in hematocrit levels for subjects in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in Hematocrit at Day 8
|
0.12 volume % of red blood cells (RBCs)
Standard Deviation 1.33
|
-0.20 volume % of red blood cells (RBCs)
Standard Deviation 1.61
|
2.40 volume % of red blood cells (RBCs)
Standard Deviation 6.67
|
-0.37 volume % of red blood cells (RBCs)
Standard Deviation 2.70
|
-0.97 volume % of red blood cells (RBCs)
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in hematocrit levels for subjects in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in Hematocrit at Day 180
|
44.54 volume % of RBCs
Standard Deviation 2.35
|
42.68 volume % of RBCs
Standard Deviation 4.59
|
41.33 volume % of RBCs
Standard Deviation 4.77
|
42.12 volume % of RBCs
Standard Deviation 2.02
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in total bilirubin and creatinine for subjects in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
Total bilirubin
|
0.100 milligrams/dL (mg/dL)
Standard Deviation 0.179
|
0.023 milligrams/dL (mg/dL)
Standard Deviation 0.416
|
0.053 milligrams/dL (mg/dL)
Standard Deviation 0.137
|
-0.033 milligrams/dL (mg/dL)
Standard Deviation 0.058
|
0.037 milligrams/dL (mg/dL)
Standard Deviation 0.102
|
|
SAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 8
Creatinine
|
-0.032 milligrams/dL (mg/dL)
Standard Deviation 0.041
|
-0.038 milligrams/dL (mg/dL)
Standard Deviation 0.059
|
0.100 milligrams/dL (mg/dL)
Standard Deviation 0.200
|
-0.063 milligrams/dL (mg/dL)
Standard Deviation 0.012
|
-0.117 milligrams/dL (mg/dL)
Standard Deviation 0.215
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in total bilirubin and creatinine for subjects in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
Total bilirubin
|
-0.043 mg/dL
Standard Deviation 0.264
|
0.067 mg/dL
Standard Deviation 0.100
|
-0.051 mg/dL
Standard Deviation 0.153
|
-0.017 mg/dL
Standard Deviation 0.112
|
—
|
|
MAD Part: Mean Change From Baseline in Total Bilirubin and Creatinine at Day 180
Creatinine
|
0.030 mg/dL
Standard Deviation 0.077
|
-0.038 mg/dL
Standard Deviation 0.100
|
-0.006 mg/dL
Standard Deviation 0.099
|
0.054 mg/dL
Standard Deviation 0.112
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in the following liver enzyme levels are presented for subjects in the SAD part of the study: alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
ALP
|
0.0 Units/Liter (U/L)
Standard Deviation 4.5
|
0.0 Units/Liter (U/L)
Standard Deviation 3.8
|
-7.7 Units/Liter (U/L)
Standard Deviation 14.2
|
3.7 Units/Liter (U/L)
Standard Deviation 7.0
|
4.0 Units/Liter (U/L)
Standard Deviation 11.7
|
|
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
ALT
|
-1.3 Units/Liter (U/L)
Standard Deviation 3.1
|
0.8 Units/Liter (U/L)
Standard Deviation 4.5
|
3.7 Units/Liter (U/L)
Standard Deviation 7.5
|
-0.3 Units/Liter (U/L)
Standard Deviation 1.5
|
-2.2 Units/Liter (U/L)
Standard Deviation 4.3
|
|
SAD Part: Mean Change From Baseline in Liver Enzymes at Day 8
AST
|
-1.0 Units/Liter (U/L)
Standard Deviation 2.5
|
-0.2 Units/Liter (U/L)
Standard Deviation 3.0
|
6.0 Units/Liter (U/L)
Standard Deviation 10.1
|
-2.7 Units/Liter (U/L)
Standard Deviation 1.5
|
-1.2 Units/Liter (U/L)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in the following liver enzyme levels are presented for subjects in the MAD part of the study: ALP, ALT and AST.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
ALP
|
1.1 U/L
Standard Deviation 7.6
|
-3.4 U/L
Standard Deviation 8.8
|
-0.2 U/L
Standard Deviation 11.6
|
-10.2 U/L
Standard Deviation 13.8
|
—
|
|
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
ALT
|
0.3 U/L
Standard Deviation 3.3
|
2.1 U/L
Standard Deviation 3.9
|
-6.6 U/L
Standard Deviation 21.1
|
-3.8 U/L
Standard Deviation 8.3
|
—
|
|
MAD Part: Mean Change From Baseline in Liver Enzymes at Day 180
AST
|
-0.7 U/L
Standard Deviation 3.1
|
0.7 U/L
Standard Deviation 3.2
|
-4.1 U/L
Standard Deviation 12.8
|
-1.1 U/L
Standard Deviation 5.8
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) for subjects in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
SBP
|
7.8 millimeters mercury (mmHg)
Standard Deviation 10.9
|
-7.3 millimeters mercury (mmHg)
Standard Deviation 18.2
|
6.0 millimeters mercury (mmHg)
Standard Deviation 12.2
|
-11.3 millimeters mercury (mmHg)
Standard Deviation 6.7
|
3.7 millimeters mercury (mmHg)
Standard Deviation 8.8
|
|
SAD Part: Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Day 8
DBP
|
4.2 millimeters mercury (mmHg)
Standard Deviation 9.2
|
-2.0 millimeters mercury (mmHg)
Standard Deviation 8.3
|
0.3 millimeters mercury (mmHg)
Standard Deviation 10.6
|
-8.3 millimeters mercury (mmHg)
Standard Deviation 9.0
|
9.0 millimeters mercury (mmHg)
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in SBP and DBP for subjects in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
SBP
|
-0.3 mmHg
Standard Deviation 20.4
|
7.7 mmHg
Standard Deviation 13.3
|
8.9 mmHg
Standard Deviation 8.5
|
-2.1 mmHg
Standard Deviation 15.3
|
—
|
|
MAD Part: Mean Change From Baseline in SBP and DBP at Day 180
DBP
|
4.6 mmHg
Standard Deviation 9.4
|
6.6 mmHg
Standard Deviation 10.3
|
1.7 mmHg
Standard Deviation 8.5
|
-3.0 mmHg
Standard Deviation 11.3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 8Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 8 in the electrocardiogram (ECG) parameter QTcF interval for subjects in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Change From Baseline in the QTcF Interval at Day 8
|
-10.7 milliseconds (msec)
Standard Deviation 25.3
|
2.3 milliseconds (msec)
Standard Deviation 14.3
|
11.7 milliseconds (msec)
Standard Deviation 6.8
|
-3.7 milliseconds (msec)
Standard Deviation 14.8
|
3.5 milliseconds (msec)
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Baseline and Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
The mean changes from baseline at Day 180 in the ECG parameter QTcF interval for subjects in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Change From Baseline in the QTcF Interval at Day 180
|
3.4 msec
Standard Deviation 24.0
|
3.9 msec
Standard Deviation 13.5
|
1.9 msec
Standard Deviation 10.1
|
-3.6 msec
Standard Deviation 14.7
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Day 29Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=6 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=3 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site erythema
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site hypersensitvity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site inflammation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint discomfort
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint inflammation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site nodule
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
SAD Part: Number of Subjects With Injection Site TEAEs
Injection site swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 180Population: The safety analysis set consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
Physical examinations were conducted by a physician or another medically-qualified individual and findings were noted at the injection site during the study. The number of subjects with injection site TEAEs, including the following, are presented: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site joint discomfort, Injection site joint inflammation, Injection site joint pain, Injection site joint swelling, Injection site nodule, Injection site pain and Injection site swelling.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=9 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site inflammation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint discomfort
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint inflammation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint pain
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site joint swelling
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site nodule
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site pain
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
MAD Part: Number of Subjects With Injection Site TEAEs
Injection site swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All Pharmacokinetic (PK) samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=3 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Maximum Plasma Concentration (Cmax)
|
9.435 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 41.4
|
0.8528 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 43.6
|
2.757 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 29.9
|
5.732 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 18.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Cmax values were obtained directly from the observed concentration versus time data, and the geometric mean Cmax values for subjects who received KA34 in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Cmax
|
—
|
2.536 ng/mL
Geometric Coefficient of Variation 33.7
|
4.807 ng/mL
Geometric Coefficient of Variation 26.7
|
10.67 ng/mL
Geometric Coefficient of Variation 40.3
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=3 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Median Time to Maximum Observed Plasma Concentration (Tmax)
|
0.30 hours (h)
Interval 0.25 to 1.03
|
0.25 hours (h)
Interval 0.25 to 0.52
|
0.50 hours (h)
Interval 0.5 to 0.53
|
0.38 hours (h)
Interval 0.22 to 0.53
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. Tmax was obtained directly from the observed concentration versus time data and the median Tmax values for subjects who received KA34 in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Median Tmax
|
—
|
0.50 h
Interval 0.23 to 0.55
|
0.30 h
Interval 0.25 to 0.5
|
0.50 h
Interval 0.28 to 1.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=3 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-t])
|
15.73 ng*h/mL
Standard Deviation 2.515
|
1.430 ng*h/mL
Standard Deviation 0.2128
|
4.473 ng*h/mL
Standard Deviation 2.555
|
9.933 ng*h/mL
Standard Deviation 2.382
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-t) was calculated by linear up/log down trapezoidal summation, and the mean AUC(0-t) values for subjects who received KA34 in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean AUC(0-t)
|
—
|
4.578 ng*h/mL
Standard Deviation 1.312
|
7.077 ng*h/mL
Standard Deviation 1.333
|
19.53 ng*h/mL
Standard Deviation 9.554
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=5 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=2 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=2 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
|
17.34 ng*h/mL
Standard Deviation 3.626
|
1.595 ng*h/mL
Standard Deviation 0.2333
|
5.425 ng*h/mL
Standard Deviation 3.953
|
11.09 ng*h/mL
Standard Deviation 2.940
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. AUC(0-inf) was calculated by linear up/log down trapezoidal summation and extrapolated to infinity by the addition of the last quantifiable concentration (Clast) divided by the elimation rate constant (λz), i.e. AUC(0-t) + Clast/λz. The mean AUC(0-inf) values are presented for subjects who received KA34 in the MAD part of the study.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=8 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean AUC(0-inf)
|
—
|
5.041 ng*h/mL
Standard Deviation 1.556
|
7.370 ng*h/mL
Standard Deviation 1.440
|
21.22 ng*h/mL
Standard Deviation 11.05
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=6 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=3 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=3 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Apparent Terminal Half-life (t1/2)
|
1.222 h
Standard Deviation 0.4439
|
1.253 h
Standard Deviation 0.7117
|
1.420 h
Standard Deviation 0.7072
|
1.145 h
Standard Deviation 0.1666
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. t1/2 was determined as the natural log of λz, i.e. as ln2/λz. Mean t1/2 values for subjects who received KA34 in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean t1/2
|
—
|
1.072 h
Standard Deviation 0.2567
|
0.9997 h
Standard Deviation 0.2991
|
0.9286 h
Standard Deviation 0.3044
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the SAD part of the study.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=5 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=2 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=2 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Apparent Clearance (CL/F)
|
23.92 L/h
Standard Deviation 5.157
|
31.70 L/h
Standard Deviation 4.667
|
25.10 L/h
Standard Deviation 18.24
|
19.22 L/h
Standard Deviation 5.466
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
All PK samples were analyzed by liquid chromatography with tandem mass spectrometry, using a validated, sensitive, specific method. The CL/F after extravascular dosing was calculated as dose divided by AUC(0-inf), and is presented for subjects who received KA34 in the MAD part of the study.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=8 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean CL/F
|
—
|
21.43 L/h
Standard Deviation 6.182
|
28.11 L/h
Standard Deviation 5.695
|
23.85 L/h
Standard Deviation 11.95
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
The Vz/F was calculated as dose divided by (λz\*AUC\[0-inf\]), and the mean Vz/F values for subjects who received KA34 in the SAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
n=5 Participants
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=2 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=2 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=6 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
SAD Part: Mean Apparent Volume of Distribution (Vz/F)
|
35.56 L
Standard Deviation 4.706
|
38.25 L
Standard Deviation 0.4950
|
34.30 L
Standard Deviation 19.66
|
31.47 L
Standard Deviation 9.479
|
—
|
SECONDARY outcome
Timeframe: Pre-dose up to 4 hours post-dose on Day 1 and pre-dose on Days 8, 15, 22 and 29Population: The PK analysis set consisted of all subjects who received KA34 and had at least 1 measured concentration at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentrations. Mean data is presented for subjects with data available for the parameter estimation.
The Vz/F was calculated as dose divided by (λz\*AUC\[0-inf\]), and the mean Vz/F values for subjects who received KA34 in the MAD part of the study are presented.
Outcome measures
| Measure |
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 5: KA34 100 µg (MAD)
n=9 Participants
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=8 Participants
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 Participants
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 4: KA34 400 µg (SAD)
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
|---|---|---|---|---|---|
|
MAD Part: Mean Vz/F
|
—
|
32.51 L
Standard Deviation 10.19
|
37.98 L
Standard Deviation 13.46
|
30.00 L
Standard Deviation 13.38
|
—
|
Adverse Events
Placebo (SAD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1: KA34 50 µg (SAD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2: KA34 100 µg (SAD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: KA34 200 µg (SAD)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4: KA34 400 µg (SAD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo (MAD)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 5: KA34 100 µg (MAD)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6: KA34 200 µg (MAD)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 7: KA34 400 µg (MAD)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (SAD)
n=6 participants at risk
Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
|
Cohort 1: KA34 50 µg (SAD)
n=3 participants at risk
Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 2: KA34 100 µg (SAD)
n=3 participants at risk
Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 3: KA34 200 µg (SAD)
n=6 participants at risk
Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 4: KA34 400 µg (SAD)
n=6 participants at risk
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Placebo (MAD)
n=9 participants at risk
Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
|
Cohort 5: KA34 100 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
Other adverse events
| Measure |
Placebo (SAD)
n=6 participants at risk
Subjects randomized to Cohorts 1 - 4 in the SAD part of the study received single IA injections of matching placebo in the affected knee and were followed up until Day 29.
|
Cohort 1: KA34 50 µg (SAD)
n=3 participants at risk
Subjects received a single IA injection of 50 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 2: KA34 100 µg (SAD)
n=3 participants at risk
Subjects received a single IA injection of 100 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 3: KA34 200 µg (SAD)
n=6 participants at risk
Subjects received a single IA injection of 200 µg KA34 in the affected knee and were followed up until Day 29.
|
Cohort 4: KA34 400 µg (SAD)
n=6 participants at risk
Subjects received a single IA injection of 400 µg KA34 in the affected knee and were followed up until Day 29.
|
Placebo (MAD)
n=9 participants at risk
Subjects randomized to Cohorts 5 - 7 in the MAD part of the study received weekly IA injections of matching placebo in the affected knee for 4 weeks and were followed up until Day 180.
|
Cohort 5: KA34 100 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 100 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 6: KA34 200 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 200 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
Cohort 7: KA34 400 µg (MAD)
n=9 participants at risk
Subjects received IA injections of 400 µg KA34 in the affected knee once weekly for 4 weeks and were followed up until Day 180.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection site nodule
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site joint discomfort
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
33.3%
1/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site joint pain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
22.2%
2/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
22.2%
2/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Chills
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site joint inflammation
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site inflammation
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site joint swelling
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
22.2%
2/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
General disorders
Injection site erythema
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
33.3%
1/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Rabies
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
33.3%
1/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
66.7%
6/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
22.2%
2/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
22.2%
2/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
33.3%
1/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
11.1%
1/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/3 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
16.7%
1/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/6 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
0.00%
0/9 • TEAEs were collected from time of first administration of IP (Day 1) up to 30 days after the last administration of IP (approximately 1 month for the SAD cohorts and approximately 6 months for the MAD cohorts).
TEAEs are presented for the safety analysis set which consisted of all subjects who received at least 1 dose of IP and were analyzed according to treatment received.
|
Additional Information
Study Director
Calibr, a Division of Scripps Research
Phone: (858) 242 1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place