NCT06482190

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shenzhen Resproly Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study consists of 3 parts. SAD Part: The participants in the SAD cohorts of the study (Cohort 1 to Cohort 5) will receive a single dose of RSN0402 at 2, 4, 8, 12, or 16 mg dose or placebo via inhalation using a dry powder inhalant. Participants from Cohort 2 will receive a single dose of 150 mg nintedanib soft capsule after 7-day washout period. After completion of Cohort 3, SRC will decide whether to enrol Cohort 4 sequentially or to skip Cohort 4 and enrol Cohort 5 directly based on the safety and PK data collected from the Cohort 1 to Cohort 3. If there are no safety concerns, Cohort 5 will be enrolled after Cohort 3. MAD Part: The MAD Part consists of 4 cohorts with 8 participants in each cohort. Participants will be randomly assigned to receive RSN0402 (4, 8, 12, or 16 mg) or placebo for 7 days at a ratio of 3:1. In MAD study, the IP will be administered once daily from Day 1 to Day 7. The doses in MAD Part of the study could be adjusted at the discretion of the SRC based on the review of data from the SAD cohorts. The dose regimen in MAD Part may also be adjusted to twice daily or another regimen if there is any concern after SRC review of the available data from SAD cohorts. The adjusted dose and dose regimen cannot exceed the maximum safety daily dose confirmed in the SAD Part.

Conditions

• Idiopathic Pulmonary Fibrosis
• Lung; Disease, Interstitial, With Fibrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-11
• Primary completion: 2024-12-27
• Completion: 2025-02-10
• First posted: 2024-07-01
• Last updated: 2024-07-08

Locations

3 sites across 1 country: Australia