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

NCT07510958 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-06

No results posted yet for this study

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

DRUG

SYH2059

Inhalation administration

DRUG

Placebo

Inhalation administration

Sponsors & Collaborators

  • InnovStone Therapeutics Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-12-31
Completion
2027-02-28

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510958 on ClinicalTrials.gov