NCT00618709

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

January 23, 2008

Last Update Submit

May 28, 2014

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

  • Safety assessed by: Laboratory tests

    12 weeks

  • Safety assessed by: medical evaluations

    24 weeks

  • Safety assessed by: ECG results

    24 weeks

Secondary Outcomes (1)

  • Pharmacokinetic profile

    24 hours, before and after dosing

Other Outcomes (1)

  • Pain assessed by visual analog scale

    24 weeks

Study Arms (4)

Cohort 1

EXPERIMENTAL

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

Drug: ATX-101

Cohort 2

EXPERIMENTAL

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

Drug: ATX-101

Cohort 3

EXPERIMENTAL

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

Drug: ATX-101

Cohort 4

EXPERIMENTAL

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

Drug: ATX-101

Interventions

ATX-101DRUG

ATX-101 single dose

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Tempe, Arizona, 85283, United States

Location

Study Officials

  • Dennis Swearingin, M.D.

    MDS Pharma Services

    PRINCIPAL INVESTIGATOR

  • Frederick Beddingfield, M.D.

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 20, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

US(1)