ClinicalTrials.Veeva

Menu

Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

K

Kythera Biopharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ATX-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT00618709
ATX-101-07-08

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

24 participants in 4 patient groups

Cohort 1
Experimental group
Description:
ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
Treatment:
Drug: ATX-101
Cohort 2
Experimental group
Description:
ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid
Treatment:
Drug: ATX-101
Cohort 3
Experimental group
Description:
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
Treatment:
Drug: ATX-101
Cohort 4
Experimental group
Description:
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
Treatment:
Drug: ATX-101

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems