Status:

COMPLETED

Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

Lead Sponsor:

Kythera Biopharmaceuticals

Conditions:

Healthy

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

24 Patients enrolled

Trial Details

Trial ID

NCT00618709

Start Date

January 1 2008

End Date

January 1 2009

Last Update

May 30 2014

Active Locations (1)

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1

MDS Pharma Services

Tempe, Arizona, United States, 85283