drugset / Trial / NCT05188261
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
RandomizedSequentialTriple-blindTreatment
Summary
This is a first-in-human study to evaluate the safety and tolerability of single ascending doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema. Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or placebo. Up to 5 different doses of IW-3300 will be studied. Safety reviews will be conducted before proceeding to each higher dose.
Timeline
- Start
- 2022-01-18
- Primary completion
- 2022-03-09
- Completion
- 2022-03-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IW-3300 | Unknown | 100 ug | Rectal |
| Subject | IW-3300 | Unknown | 300 ug | Rectal |
| Subject | IW-3300 | Unknown | 900 ug | Rectal |
| Subject | IW-3300 | Unknown | 2500 ug | Rectal |
Indications
No indication recorded.