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Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

NCT01372761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-12-30

No results posted yet for this study

Summary

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Conditions

Interventions

DRUG

ZGN-433

Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

DRUG

Normal Saline

Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Sponsors & Collaborators

  • Zafgen, Inc.

    lead INDUSTRY

Principal Investigators

  • J K Marjason, MD · Q-Pharm Clinics, Royal Brisbane and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372761 on ClinicalTrials.gov