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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618709

Enrollment

Registered

2008-02-20

Start date

2008-01-31

Completion date

2009-01-31

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteers

Brief 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.

Interventions

DRUGATX-101

ATX-101 single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males or nonpregnant females * Age 18 to 65 * Sufficient submental fat for injections * Signed informed consent

Exclusion criteria

* Prior interventions in the chin or neck area * History or presence of drug or alcohol abuse * Treatment with an investigational agent within 30 days before the dose

Design outcomes

Primary

Measure	Time frame
Safety assessed by: Laboratory tests	12 weeks
Safety assessed by: medical evaluations	24 weeks
Safety assessed by: ECG results	24 weeks

Secondary

Measure	Time frame	Description
Pharmacokinetic profile	24 hours, before and after dosing	Cmax, tmax, AUC

Other

Measure	Time frame
Pain assessed by visual analog scale	24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026