Trials / Completed
CompletedNCT00618709
Dose-Escalation Safety and Pharmacokinetic Study of ATX-101
Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Kythera Biopharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101
Detailed description
This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATX-101 | ATX-101 single dose |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2008-12-01
- Completion
- 2009-01-01
- First posted
- 2008-02-20
- Last updated
- 2014-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00618709. Inclusion in this directory is not an endorsement.