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NOT YET RECRUITING
NCT07844954
PHASE1

Safety, Tolerability, and Pharmacokinetics of DM1001 Transdermal Patch in Healthy Chinese Participants

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This is a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the DM1001 transdermal patch in healthy Chinese participants. Eligible participants will receive DM1001 according to the clinical trial protocol. Safety, tolerability, and pharmacokinetic assessments will be conducted at prespecified time points during the study. The study is intended to provide initial information on the safety, tolerability, and pharmacokinetic characteristics of DM1001 in humans.

Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of the DM1001 Transdermal Patch in Healthy Chinese Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-09-30

Completion Date

2027-12-31

Last Updated

2026-09-28

Healthy Volunteers

Yes

Interventions

DRUG

DM1001 Transdermal Patch

DM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites.

DRUG

Matching Placebo Transdermal Patch

Matching placebo transdermal patch containing 0 mg per 10 cm2, administered in Cohorts 1 and 3 according to the randomized, double-blind study design.

DRUG

Pramipexole Extended-Release Tablet

Oral pramipexole extended-release tablets administered at 0.375 mg, 0.75 mg, and 1.5 mg once daily during Weeks 1, 2, and 3, respectively.