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A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in Healthy Chinese Participants

NCT06308523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-10-22

No results posted yet for this study

Summary

The study will be a single center, double-blind, randomized, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, PK and PD of AP303 following 2-week oral administration to healthy Chinese participants.

Conditions

  • Healthy Subjects

Interventions

DRUG

AP303 150 μg

AP303 Tablet 150 μg QD

DRUG

Placebo 150 μg

Placebo Tablet 150 μg QD

DRUG

AP303 300 μg

AP303 Tablet 300 μg QD

DRUG

Placebo 300 μg

Placebo Tablet 300 μg QD

Sponsors & Collaborators

  • Alebund Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2024-05-13
Completion
2024-05-13

Countries

  • China

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 NCT06308523 on ClinicalTrials.gov