Trials / Completed
CompletedNCT05036512
A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, PK, and Food Effect of GBT021601, a Hemoglobin S Polymerization Inhibitor, in Healthy Participants.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.
Detailed description
This is a randomized, double-blind, placebo controlled, single and multiple ascending dose study in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GBT021601 | Administered orally with water as a single dose in the morning. |
Timeline
- Start date
- 2020-12-09
- Primary completion
- 2022-11-02
- Completion
- 2023-02-07
- First posted
- 2021-09-05
- Last updated
- 2023-07-25
Locations
4 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05036512. Inclusion in this directory is not an endorsement.