Trial Outcomes & Findings for A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects (NCT NCT05362695)
NCT ID: NCT05362695
Last Updated: 2024-02-02
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
From first dose of study drug through 24 hours post-Day 1 dose
Results posted on
2024-02-02
Participant Flow
The study was designed to include up to 3 cohorts with 9 participants per cohort. Within each cohort, participants were randomized to receive a single dose of IW-3300 (6 participants) or placebo (3 participants). Doses to be evaluated were 100 and 300 μg. An optional 3rd cohort was planned to test an IW-3300 dose of \>100 μg but \<300 μg. Based on a blinded review of safety and tolerability data from Cohorts 1 and 2, the Dose Escalation Committee decided not to enroll the optional 3rd Cohort.
As pre-specified by the statistical analysis plan, for the analyses reported herein, data from the 3 participants dosed with placebo in each of the 2 cohorts were pooled into a single placebo group (N=6).
Participant milestones
| Measure |
Placebo
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
100 μg IW-3300
A 100 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
300 μg IW-3300
A 300 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
100 μg IW-3300
n=6 Participants
A 100 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
300 μg IW-3300
n=6 Participants
A 300 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 9.52 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 13.50 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 11.54 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 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
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 24 hours post-Day 1 dosePopulation: Safety Analysis Set (all participants who received any amount of study drug)
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
100 μg IW-3300
n=6 Participants
A 100 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
300 μg IW-3300
n=6 Participants
A 300 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through 24 hours post-Day 1 dosePopulation: Safety Analysis Set (all participants who received any amount of study drug)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is lifethreatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
100 μg IW-3300
n=6 Participants
A 100 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
300 μg IW-3300
n=6 Participants
A 300 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
|---|---|---|---|
|
Number of Participants With Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 μg IW-3300
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
300 μg IW-3300
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
100 μg IW-3300
n=6 participants at risk
A 100 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
300 μg IW-3300
n=6 participants at risk
A 300 μg dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) once daily for 7 days
|
|---|---|---|---|
|
Eye disorders
Corneal irritation
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
0.00%
0/6 • From first dose of study drug through 24 hours post-Day 1 dose
An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.
- Publication restrictions are in place
Restriction type: OTHER