Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05362695 | A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects | PHASE1 | COMPLETED | 18 | — | — | May 17, 2022 | Jul 13, 2022 | Feb 2, 2024 | 1 | United States |
| NCT05188261 | A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers | PHASE1 | COMPLETED | 32 | — | — | Jan 18, 2022 | Mar 21, 2022 | Dec 8, 2023 | 1 | United States |
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: 100 μg IW-3300 | EXPERIMENTAL | 100 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 2: 300 μg IW-3300 | EXPERIMENTAL | 300 μg dose of active drug (IW-3300) once daily for 7 days |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | matching placebo once daily for 7 days |
| Cohort 3 (optional): Dose 3 | EXPERIMENTAL | Active drug (IW-3300) once daily for 7 days |
| Cohort 3 (optional): Placebo | PLACEBO_COMPARATOR | Matching placebo once daily for 7 days |
| Cohort 3: 900 μg IW-3300 | EXPERIMENTAL | Dose 3: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Cohort 4: 2500 μg IW-3300 | EXPERIMENTAL | Dose 4: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 4: Placebo | PLACEBO_COMPARATOR | Within the cohort, 2 participants will receive the matching placebo dose |
| Name | Type | Description |
|---|---|---|
| IW-3300 | DRUG | A dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema). |
| Placebo | DRUG | A dose of placebo administered rectally (as a low-volume \[20 mL\] enema). |
Inclusion Criteria: * Males and female subjects of non-childbearing potential * Ages 18 to 60 years * Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests. * Body mass index...