Trials / Completed
CompletedNCT03490786
A Dose Escalating Study to Assess the Safety and Tolerability of GT-001
A Dose Escalating Study to Assess the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Lingual Application of GT-001 in Subjects With Obesity.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Gila Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Dose escalation study of GT-001
Detailed description
This is a dose-escalation design trial. Twelve evaluable subjects (n=12) with BMIs of 30 to 40 kg/m2 will receive a single dose of placebo followed by study drug applied directly to the surface of the tongue mucosa with a disposable pipette followed by a one-day washout. A total of seven (7) doses will escalate to a dose of 2.5 mg.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GT-001 | PK, PD Study to Determine Safety of Escalating Doses of GT-001 |
Timeline
- Start date
- 2017-07-16
- Primary completion
- 2017-08-09
- Completion
- 2017-10-02
- First posted
- 2018-04-06
- Last updated
- 2018-04-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03490786. Inclusion in this directory is not an endorsement.