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A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects

NCT05503693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-05-30

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

AP303 50 μg

AP303 tablet

DRUG

AP303 150 μg

AP303 tablet

DRUG

AP303 300 μg

AP303 tablet

DRUG

AP303 600 μg

AP303 tablet

DRUG

Placebo 50 μg

Placebo tablet

DRUG

Placebo 150 μg

Placebo tablet

DRUG

Placebo 300 μg

Placebo tablet

DRUG

Placebo 600 μg

Placebo tablet

Sponsors & Collaborators

  • Alebund Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Sam Francis, Doctor · Nucleus Network

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
2022-12-06
Primary Completion
2023-07-21
Completion
2023-07-21

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 NCT05503693 on ClinicalTrials.gov