A Phase 1 interventional study of DM1001 Transdermal Patch and Matching Placebo Transdermal Patch in Healthy Participants, sponsored by The Third Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The Third Xiangya Hospital of Central South University · Phase 1, Interventional, and Other
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.
This is a Phase 1 registration drug clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of the DM1001 transdermal patch in healthy Chinese participants.
The investigational product is the DM1001 transdermal patch. The study will be conducted according to the approved clinical trial protocol. In China, the study is classified as a Class 2.2 chemical drug clinical trial.
The study will evaluate the safety and tolerability of DM1001 and characterize its pharmacokinetic properties during the clinical trial. Safety, tolerability, and pharmacokinetic assessments will be performed according to the procedures and time points specified in the clinical trial protocol.
The study is being conducted by the Phase I Clinical Research Unit of the Third Xiangya Hospital of Central South University. The principal investigators are Guoping Yang and Chengxian Guo.
The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive DM1001 transdermal patch in Cohorts 1, 3, 4, 5, and 6. Doses include 2.8 mg, 5.6 mg, and 11.2 mg according to the cohort-specific schedule. The patch is applied to the upper arm, upper back, or outer thigh according to the cohort. Cohorts 1 and 3 are randomized in a 3:1 ratio to DM1001 or matching placebo, whereas Cohorts 4, 5, and 6 are open-label.
Drug: DM1001 Transdermal Patch
Participants in Cohorts 1 and 3 receive matching placebo transdermal patch according to the randomized, double-blind, placebo-controlled design. Participants are randomized in a 3:1 ratio to DM1001 or matching placebo.
Drug: Matching Placebo Transdermal Patch
Participants in Cohort 2 receive oral pramipexole extended-release tablets at 0.375 mg once daily during Week 1, 0.75 mg once daily during Week 2, and 1.5 mg once daily during Week 3.
Drug: Pramipexole Extended-Release Tablet
DM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites.
Matching placebo transdermal patch containing 0 mg per 10 cm2, administered in Cohorts 1 and 3 according to the randomized, double-blind study design.
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.
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.
Time frame: From first administration through the end of safety follow-up, up to Day 11, Day 24, Day 25, or Day 46 depending on the cohort.
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 frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
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.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following DM1001 Transdermal Patch Administration
The apparent terminal elimination half-life is the time required for the plasma concentration of pramipexole to decrease by one-half during the terminal elimination phase following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Pramipexole Following DM1001 Transdermal Patch Administration.
AUC0-t is the area under the plasma pramipexole concentration-time curve from time zero to the time of the last quantifiable plasma concentration following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following DM1001 Transdermal Patch Administration
AUC0-inf is the total area under the plasma pramipexole concentration-time curve from time zero extrapolated to infinity following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Total Clearance (CL/F) of Pramipexole Following DM1001 Transdermal Patch Administration
CL/F is the apparent total clearance of pramipexole from plasma following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Volume of Distribution (Vd/F) of Pramipexole Following DM1001 Transdermal Patch Administration
Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Mean Residence Time (MRT) of Pramipexole Following DM1001 Transdermal Patch Administration
MRT is the estimated average time that pramipexole remains in the body following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following DM1001 Transdermal Patch Administration
AUC%Extrap is the percentage of AUC0-inf attributable to extrapolation from the last quantifiable plasma concentration to infinity following administration of the DM1001 transdermal patch.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Css,max is the highest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Time to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Tss,max is the elapsed time from administration to the maximum observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following DM1001 Transdermal Patch Administration
Css,min is the lowest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following DM1001 Transdermal Patch Administration
AUCss is the area under the plasma pramipexole concentration-time curve over one dosing interval at steady state following administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following DM1001 Transdermal Patch Administration
RAUC is the accumulation ratio of pramipexole calculated by comparing the area under the plasma concentration-time curve at steady state with the corresponding area under the curve after the initial administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following DM1001 Transdermal Patch Administration
RCmax is the accumulation ratio of pramipexole calculated by comparing the maximum observed plasma concentration at steady state with the maximum observed plasma concentration after the initial administration of the DM1001 transdermal patch.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Maximum Observed Plasma Concentration (Cmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Cmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets.
Time frame: From pre-dose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Time to Maximum Observed Plasma Concentration (Tmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Tmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Terminal Elimination Rate Constant (Lambda z) of Pramipexole Following Oral Pramipexole Extended-Release Tablet 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 oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
The apparent terminal elimination half-life is the time required for the plasma concentration of pramipexole to decrease by one-half during the terminal elimination phase following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration.
AUC0-t is the area under the plasma pramipexole concentration-time curve from time zero to the time of the last quantifiable plasma concentration following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
AUC0-inf is the total area under the plasma pramipexole concentration-time curve from time zero extrapolated to infinity following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Total Clearance (CL/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
CL/F is the apparent total clearance of pramipexole from plasma following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Apparent Volume of Distribution (Vd/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Mean Residence Time (MRT) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
MRT is the estimated average time that pramipexole remains in the body following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
AUC%Extrap is the percentage of AUC0-inf attributable to extrapolation from the last quantifiable plasma concentration to infinity following administration of oral pramipexole extended-release tablets.
Time frame: From predose through the last pharmacokinetic sample: Day 11 for Cohorts 1, 5, and 6; Day 24 for Cohort 2; Day 25 for Cohort 3; and Day 46 for Cohort 4.
Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Css,max is the highest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Time to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Tss,max is the elapsed time from administration to the maximum observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Css,min is the lowest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
AUCss is the area under the plasma pramipexole concentration-time curve over one dosing interval at steady state following administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
RAUC is the accumulation ratio of pramipexole calculated by comparing the area under the plasma concentration-time curve at steady state with the corresponding area under the curve after the initial administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
RCmax is the accumulation ratio of pramipexole calculated by comparing the maximum observed plasma concentration at steady state with the maximum observed plasma concentration after the initial administration of oral pramipexole extended-release tablets.
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Time frame: Before patch application and at 1, 24, and 48 hours after patch removal; assessment may be extended to Day 7 or Day 14 if necessary.
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.
Time frame: Within 1 hour after each patch application and at 12, 24, and every 24 hours thereafter through patch removal at 168 hours.
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.
Time frame: Assessed at each scheduled patch removal (168 hours after application): Day 8 for Cohorts 1, 5, and 6; Days 8, 15, and 22 for Cohort 3; and Days 8, 15, 22, 29, 36, and 43 for Cohort 4.
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The Third Xiangya Hospital of Central South University