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Trials / Completed

CompletedNCT07098117

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects.

Conditions

Interventions

TypeNameDescription
DRUGSHR0302 Base GelPart I: once daily. Part 2:, twice daily.
DRUGSHR0302 Base Gel PlaceboPart I: once daily. Part II: twice daily.

Timeline

Start date
2024-06-19
Primary completion
2024-07-31
Completion
2024-07-31
First posted
2025-08-01
Last updated
2025-08-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07098117. Inclusion in this directory is not an endorsement.

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile (NCT07098117) · Clinical Trials Directory