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

Phase 1 Unknown 72 enrolled Shenzhen Resproly Biopharmaceutical Co., Ltd Resproly Australia Pty Ltd · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2024-07-11
Primary completion: 2024-12-27
Completion: 2025-02-10

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSN0402	Unknown	2 mg	Inhaled
Subject	RSN0402	Unknown	4 mg	Inhaled
Subject	RSN0402	Unknown	8 mg	Inhaled
Subject	RSN0402	Unknown	12 mg	Inhaled
Subject	RSN0402	Unknown	16 mg	Inhaled
Background	Nintedanib	Small molecule	150 mg	—

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

Summary

Timeline

Drugs

Indications