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Safety, Tolerability, and Pharmacokinetics of DM1001 Transdermal Patch in Healthy Chinese Participants
Sponsor: The Third Xiangya Hospital of Central South University
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
Conditions
Interventions
DM1001 Transdermal Patch
DM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites.
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.
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.