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.
Criterion 1. Healthy male or female participants aged 18 to 55 years, inclusive, at the time of informed consent.
Criterion 2. Body weight of at least 50 kg for males and at least 45 kg for females.
Criterion 3. BMI between 18 and 28 kg/m², inclusive.
Criterion 4. Able to understand the study procedures and potential risks, provide written informed consent, communicate effectively with the investigator, and comply with all study requirements.
Criterion 1. Clinically significant disease or dysfunction, including neurological, psychiatric, cardiovascular, gastrointestinal, respiratory, renal, metabolic, endocrine, dermatological, hematological, immunological, or malignant disease.
Criterion 2. Any condition or history of surgery that may affect drug absorption, distribution, metabolism, or excretion, or may place the participant at unacceptable risk.
Criterion 3. Significant history of drug or skin allergy, or known allergy to any study intervention component.
Criterion 4. Current or previous psychiatric or brain disorder, suicide risk according to the Columbia-Suicide Severity Rating Scale, or history of self-harm.
Sequential
DM1001 Transdermal Patch
DrugDM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites.
Matching Placebo Transdermal Patch
DrugMatching 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
DrugOral 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.
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Study Withdrawal
Incidence, severity, seriousness, and relationship to study intervention, including changes in vital signs, physical examination, 12-lead ECG, hematology, urinalysis, clinical chemistry, coagulation, and prolactin.
Maximum Observed Plasma Concentration (Cmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Cmax derived from observed plasma pramipexole concentration-time data following administration of the DM1001 transdermal patch.
Time to Maximum Observed Plasma Concentration (Tmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Tmax derived from observed plasma pramipexole concentration-time data following administration of the DM1001 transdermal patch.
Terminal Elimination Rate Constant (Lambda z) of Pramipexole Following DM1001 Transdermal Patch Administration
Lambda z is the terminal elimination rate constant of pramipexole estimated from the terminal log-linear portion of the plasma concentration-time curve following administration of the DM1001 transdermal patch.
Number of Participants With Skin Irritation at the Application Site Assessed Using the Predefined Skin Reaction Score
Number of participants with skin irritation at the patch application and control sites, assessed using the predefined skin reaction score (range 0-7) and other effect categories (A-H). The number and percentage of participants in each score category will be reported.
Mean DM1001 Patch Adhesion Score at Each Scheduled Assessment
Patch adhesion assessed at 0, 12, and 24 hours after application and every 24 hours thereafter until patch removal.
Mean Transdermal Absorption Percentage of Pramipexole From DM1001 Patches Based on Residual Drug Content
Used DM1001 patches will be collected at each scheduled patch removal. The transdermal absorption percentage of pramipexole from each patch will be derived from the residual drug content measured in the used patch using the prespecified calculation method.
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The Third Xiangya Hospital of Central South University
Lead sponsor
Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
Collaborator
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