Trials / Completed
CompletedNCT05490316
A Study of IBI353 (Orismilast) in Chinese Healthy Adults
A Phase I Randomized, Double-Blind, Placebo-Controlled, Multiple Oral Dose Trial to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IBI353 (Orismilast) in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD of multiple dose of modified-release IBI353 administered orally in healthy subjects. The study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment period and 1 week of safety follow up after completion of last dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBI353 (Orismilast) | dose 1 or dose 2 |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2022-11-30
- Primary completion
- 2022-11-30
- Completion
- 2022-12-30
- First posted
- 2022-08-05
- Last updated
- 2023-05-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05490316. Inclusion in this directory is not an endorsement.