Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06482190
PHASE1

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

Sponsor: Shenzhen Resproly Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers. A total of about 72 participants are expected to be enrolled.

Official title: A Phase 1, Randomized, Double Blinded, Placebo Controlled, First-in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of RSN0402 in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-07-11

Completion Date

2025-02-10

Last Updated

2024-07-08

Healthy Volunteers

Yes

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.

Locations (3)

Nucleus Network Pty Ltd

Geelong, Victoria, Australia

Nucleus Network

Melbourne, Victoria, Australia

Nucleus Network Pty Ltd

Melbourne, Australia