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Assessment of the Safety, Tolerability, and Pharmacokinetic of GMA106

NCT05054530 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-01-30

No results posted yet for this study

Summary

This will be a single centre, Phase 1, placebo-control, randomized, double-blind, sequential single and multiple ascending dose study to assess the safety, tolerability, and PK of GMA106 in healthy, overweight or obese subjects.

Conditions

  • Overweight and Obesity

Interventions

DRUG

GMA106 Injection

GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.

DRUG

GMA106 Matching Placebo

Matching Placebo for GMA106

Sponsors & Collaborators

  • Gmax Biopharm Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, Prof · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2023-11-17
Completion
2023-11-17

Countries

  • Australia

Study Locations

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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 NCT05054530 on ClinicalTrials.gov