Trial Outcomes & Findings for A Phase 1 Study of EXT608 in Healthy Adults (NCT NCT05408663)
NCT ID: NCT05408663
Last Updated: 2025-02-04
Results Overview
Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo Comparator
Six participants (one per cohort) received matching placebo administered as a subcutaneous injection
|
Experimental- EXT608 4ug
Cohort 1: 4 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 12 ug
Cohort 2: 12 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 36 ug
Cohort 3: 36 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 108 ug
Cohort 4: 108 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 324 ug
Cohort 5: 324 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 216 ug
Cohort 6: 216 ug Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Study of EXT608 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Placebo Comparator
n=6 Participants
Six participants (one per cohort) received matching placebo administered as a subcutaneous injection
|
Experimental- EXT608 4ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 12 ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 36ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 108ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 324ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 216ug
n=3 Participants
Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
3 participants
n=8 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Incidence, nature and severity of adverse events (AEs) and withdrawals due to Treatment-Emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Characterize the Safety and Tolerability of EXT608
Adverse Event
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Characterize the Safety and Tolerability of EXT608
Any AE That Might Be Related to Study Drug
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Characterize the Safety and Tolerability of EXT608
Serious Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Characterize the Safety and Tolerability of EXT608
No Adverse Event
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Characterize the Safety and Tolerability of EXT608
Withdrawal from Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 28Frequency and severity of post-dose change from baseline of hematology, serum chemistry, urinalysis, electrocardiogram (ECG), vital signs and physical examination findings
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Characterize the Safety and Tolerability of EXT608
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 28Percentage of participants with injection or infusion site reactions - edema
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Characterize the Safety and Tolerability of EXT608
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Area under the curve
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Single Dose Pharmacokinetics (PK) - Area Under the Curve (AUC)
|
NA pg*Day/mL
Standard Deviation NA
below the level of detection
|
NA pg*Day/mL
Standard Deviation NA
below the level of detection
|
NA pg*Day/mL
Standard Deviation NA
below the level of detection
|
358.3 pg*Day/mL
Standard Deviation 119.2
|
1613 pg*Day/mL
Standard Deviation 379.3
|
4903 pg*Day/mL
Standard Deviation 475.7
|
2091 pg*Day/mL
Standard Deviation 794.3
|
SECONDARY outcome
Timeframe: 0-24 hrMaximum observed concentration
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Single Dose PK - Cmax
|
NA pg/mL
Standard Deviation NA
below the level of detection
|
NA pg/mL
Standard Deviation NA
below the level of detection
|
NA pg/mL
Standard Deviation NA
below the level of detection
|
489.3 pg/mL
Standard Deviation 271.1
|
1156 pg/mL
Standard Deviation 339
|
4967 pg/mL
Standard Deviation 1950
|
1266 pg/mL
Standard Deviation 489.4
|
SECONDARY outcome
Timeframe: Day 0 to Day 7Time to reach maximum observed plasma concentration
Outcome measures
| Measure |
Placebo - Comparator
n=6 Participants
Six participants (1 in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental - EXT608 4 ug
n=3 Participants
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 12 ug
n=3 Participants
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 36 ug
n=3 Participants
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 108 ug
n=3 Participants
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 324 ug
n=3 Participants
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental - EXT608 216 ug
n=3 Participants
Cohort 6: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Single Dose PK - Tmax
|
NA hr
Standard Deviation NA
below the level of detection
|
NA hr
Standard Deviation NA
below the level of detection
|
NA hr
Standard Deviation NA
below the level of detection
|
3.3 hr
Standard Deviation 1.15
|
5.3 hr
Standard Deviation 2.30
|
2.7 hr
Standard Deviation 1.16
|
4.0 hr
Standard Deviation 0.03
|
Adverse Events
Placebo Comparator
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental- EXT608 4 ug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental- EXT608 12 ug
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental- EXT608 36 ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental- EXT608 108 ug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental- EXT608 324 ug
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental- EXT608 216 ug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Comparator
n=6 participants at risk
Six participants (1 participant in each of 6 sequential dose escalation cohorts) received matching placebo administered as a subcutaneous injection
|
Experimental- EXT608 4 ug
n=3 participants at risk
Cohort 1: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 12 ug
n=3 participants at risk
Cohort 2: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 36 ug
n=3 participants at risk
Cohort 3: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 108 ug
n=3 participants at risk
Cohort 4: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 324 ug
n=3 participants at risk
Cohort 5: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
Experimental- EXT608 216 ug
n=3 participants at risk
Cohort 7: Three participants received a single dose of EXT608 administered as a subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
66.7%
2/3 • Number of events 2 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
66.7%
2/3 • Number of events 2 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
33.3%
1/3 • Number of events 1 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
0.00%
0/3 • 28 days
Adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality Disclosure Agreement
- Publication restrictions are in place
Restriction type: OTHER