Trials / Completed
CompletedNCT04044339
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects
A Double-blind, Randomized, Placebo-controlled, Sponsor-open, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-5202 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- All
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TD-5202 | Study Drug to be administered orally |
| DRUG | Placebo | Placebo to be administered orally |
Timeline
- Start date
- 2019-08-08
- Primary completion
- 2019-11-27
- Completion
- 2019-11-27
- First posted
- 2019-08-05
- Last updated
- 2021-01-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04044339. Inclusion in this directory is not an endorsement.