NCT07510958

A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: InnovStone Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Randomized, double-blind and placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of SYH2059 powder for inhalation after single and multiple doses in healthy subjects. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2059 powder for inhalation. Part 2 is to assess the safety, tolerability and pharmacokinetics of a multiple ascending dose of SYH2059 powder for inhalation.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	SYH2059	Inhalation administration
DRUG	Placebo	Inhalation administration

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-12-31
• Completion: 2027-02-28
• First posted: 2026-04-06
• Last updated: 2026-04-06