A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 11, 2024

Primary Completion Date

December 27, 2024

Study Completion Date

February 10, 2025

Conditions
Idiopathic Pulmonary FibrosisLung; Disease, Interstitial, With Fibrosis
Interventions
DRUG

RSN0402 Part 1

Participants will receive single ascending doses of 2mg, 4mg, 8mg, 12 mg, and 16mg of RSN0402 or placebo on Day 1 for Cohort 1 to 5. Cohort 2(4mg) will also a single dose of 150 mg nintedanib soft capsule will be administered orally after at least 7-days washout period.

DRUG

RSN0402 Part 2

Participants will receive multiple ascending doses of 4mg ,8mg,12mg ,16mg of RSN0402 or placebo administered once daily from Day 1 to Day 7 for Cohort 6 to 9.

DRUG

Placebo

Participants will receive matching placebo across Part 1 and Part 2 of the study.

Trial Locations (3)

3004

RECRUITING

Nucleus Network, Melbourne

RECRUITING

Nucleus Network Pty Ltd, Melbourne

3220

RECRUITING

Nucleus Network Pty Ltd, Geelong

All Listed Sponsors
collaborator

Resproly Australia Pty Ltd

INDUSTRY

lead

Shenzhen Resproly Biopharmaceutical Co., Ltd

INDUSTRY