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QG101-23-0 Capsules SAD and MAD Study in Healthy Subjects

NCT05650528 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-11-27

No results posted yet for this study

Summary

The study will consist of three parts: a single-dose ascending (SAD) phase (Part A) enrolling a total of five \~ six cohorts of healthy participants, a multiple-dose ascending (MAD) phase (Part B) enrolling 3 cohorts of healthy participants, and a food effect study (Part C).

Conditions

  • Healthy Volunteers

Interventions

DRUG

QG101-23-0 capsules

Single and Multiple Dose for oral

DRUG

Placebo

Single and Multiple Dose for oral

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Amckaus PTY LTD.

    lead INDUSTRY

Principal Investigators

  • Angela Rowland · CMAX Clinical Research Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-01-24
Completion
2024-02-26

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05650528 on ClinicalTrials.gov