Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Cohort 1

ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid

Group Type EXPERIMENTAL

ATX-101

Intervention Type DRUG

ATX-101 single dose

Cohort 2

ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid

Group Type EXPERIMENTAL

ATX-101

Intervention Type DRUG

ATX-101 single dose

Cohort 3

3 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid

Group Type EXPERIMENTAL

ATX-101

Intervention Type DRUG

ATX-101 single dose

Cohort 4

3 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid

Group Type EXPERIMENTAL

ATX-101

Intervention Type DRUG

ATX-101 single dose

Interventions

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ATX-101

ATX-101 single dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes