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A Pharmacodynamic Effect Study of AP301 in Healthy Volunteers

NCT06100627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-10

No results posted yet for this study

Summary

This is a randomized, open-label, parallel-group, phase 1 study to evaluate the PD effect of AP301 capsule in healthy volunteers. The study is planned to have 4 treatment arms: Arm 1: 2.10 g/day; arm 2: 4.20 g/day; arm 3: 6.30 g/day; arm 4: 8.40 g/day.

Conditions

  • Healthy Subjects

Interventions

DRUG

AP301

Orally administered

Sponsors & Collaborators

  • Alebund Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Sam Francis, Doctor · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2024-02-08
Completion
2024-02-28

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 NCT06100627 on ClinicalTrials.gov