Healthy ParticipantsPhase 1NCT07844954
Safety, Tolerability, and Pharmacokinetics of DM1001 Transdermal Patch in Healthy Chinese Participants
A Phase 1 study testing DM1001 Transdermal Patch and Pramipexole Extended-Release Tablet in people with Healthy Participants, run by The Third Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- DM1001 Transdermal Patch and Pramipexole Extended-Release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Criterion 5. History of drug or substance abuse, positive urine drug screen, alcohol abuse, or positive alcohol breath test.
- Criterion 6. Smoking of 5 or more cigarettes per day or consumption of 5 or more cups of coffee or tea per day within the specified period, or inability to discontinue these activities during the study.
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- Criterion 7. Unhealed skin disease or unsuitable application sites, including excessive hair, sunburn, raised moles, scars, wounds, tattoos, abnormal pigmentation, excessive sweating, or other conditions that may interfere with patch application or skin assessment.
- Criterion 8. Pregnancy or breastfeeding, positive pregnancy test, plans for pregnancy during the study or within 6 months after the study, or unwillingness to use effective contraception.
- Criterion 9. Clinically significant abnormalities in physical examination, vital signs, laboratory tests, chest imaging, ultrasound, or electrocardiogram, including QTcF of 450 ms or greater in males or 460 ms or greater in females.
- Criterion 10. Resting pulse rate below 55 or above 100 beats per minute, systolic blood pressure below 90 or at least 140 mmHg, or diastolic blood pressure below 60 or at least 90 mmHg.
- Criterion 11. Positive test results for HBsAg, HCV antibody, HIV antibody, or syphilis testing.
- Criterion 12. ALT or creatinine above the upper limit of normal, or serum prolactin greater than twice the upper limit of normal.
- Criterion 13. Blood donation or blood loss meeting the protocol-defined limits, recent surgery, use of any medication within 2 weeks before study dosing, participation in another clinical trial within 3 months, or vaccination within 30 days.
- Criterion 14. Any other condition, poor compliance, or circumstance that, in the investigator's judgment, makes the participant unsuitable for the study.
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of the DM1001 Transdermal Patch in Healthy Chinese Participants
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.
Read the detailed description
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.
- Conditions
- Healthy Participants
- Being tested
- DM1001 Transdermal Patch, Matching Placebo Transdermal Patch, Pramipexole Extended-Release Tablet
- Keywords
- DM1001, Transdermal Patch, Safety, Tolerability, Pharmacokinetics, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM1001 Transdermal PatchDrug
DM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites.
Matching Placebo Transdermal PatchDrug
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 TabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DM1001 Transdermal Patch | Experimental | 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. Receives: Drug: DM1001 Transdermal Patch |
| Matching Placebo Transdermal Patch | Placebo comparator | 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. Receives: Drug: Matching Placebo Transdermal Patch |
| Pramipexole Extended-Release Tablet | Active comparator | 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. Receives: Drug: Pramipexole Extended-Release Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844954
- Sponsor's protocol ID
- DM1001
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of the DM1001 Transdermal Patch in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07844954
- Acronym / sponsor ID
- DM1001
- Conditions
- Healthy Participants
- Keywords
- DM1001, Transdermal Patch, Safety, Tolerability, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM1001 Transdermal Patch | Experimental | Drug: DM1001 Transdermal PatchParticipants 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. |
| Matching Placebo Transdermal Patch | Placebo comparator | Drug: Matching Placebo Transdermal PatchParticipants 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. |
| Pramipexole Extended-Release Tablet | Active comparator | Drug: Pramipexole Extended-Release TabletParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
- Criterion 5. History of drug or substance abuse, positive urine drug screen, alcohol abuse, or positive alcohol breath test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM1001 Transdermal PatchDM1001 transdermal patch containing pramipexole, administered at cohort-specific doses and application sites. | Drug | DM1001 Transdermal Patch |
| Matching Placebo Transdermal PatchMatching placebo transdermal patch containing 0 mg per 10 cm2, administered in Cohorts 1 and 3 according to the randomized, double-blind study design. | Drug | Matching Placebo Transdermal Patch |
| Pramipexole Extended-Release TabletOral 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. | Drug | Pramipexole Extended-Release Tablet |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Study Withdrawal
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.
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
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.
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
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.
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
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.
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.
Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
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.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Pramipexole Following DM1001 Transdermal Patch Administration.
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.
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.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
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.
Apparent Total Clearance (CL/F) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
CL/F is the apparent total clearance of pramipexole from plasma following administration of the DM1001 transdermal patch.
Apparent Volume of Distribution (Vd/F) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of the DM1001 transdermal patch.
Mean Residence Time (MRT) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
MRT is the estimated average time that pramipexole remains in the body following administration of the DM1001 transdermal patch.
Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following DM1001 Transdermal Patch Administration
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.
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.
Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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 to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
Css,min is the lowest observed plasma concentration of pramipexole during a dosing interval at steady state following administration of the DM1001 transdermal patch.
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following DM1001 Transdermal Patch Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Maximum Observed Plasma Concentration (Cmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
Cmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets.
Time to Maximum Observed Plasma Concentration (Tmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
Tmax derived from observed plasma pramipexole concentration-time data following administration of oral pramipexole extended-release tablets.
Terminal Elimination Rate Constant (Lambda z) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
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.
Apparent Terminal Elimination Half-Life (t1/2) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
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.
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.
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.
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.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
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.
Apparent Total Clearance (CL/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
CL/F is the apparent total clearance of pramipexole from plasma following administration of oral pramipexole extended-release tablets.
Apparent Volume of Distribution (Vd/F) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
Vd/F is the apparent volume of distribution of pramipexole during the terminal elimination phase following administration of oral pramipexole extended-release tablets.
Mean Residence Time (MRT) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
MRT is the estimated average time that pramipexole remains in the body following administration of oral pramipexole extended-release tablets.
Percentage of AUC Extrapolated to Infinity (AUC%Extrap) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
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.
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.
Maximum Observed Steady-State Plasma Concentration (Css,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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 to Maximum Observed Steady-State Plasma Concentration (Tss,max) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Minimum Observed Steady-State Plasma Concentration (Css,min) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval at Steady State (AUCss) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Accumulation Ratio Based on AUC (RAUC) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
Accumulation Ratio Based on Cmax (RCmax) of Pramipexole Following Oral Pramipexole Extended-Release Tablet Administration
Time frame: From predose through completion of steady-state pharmacokinetic sampling: Day 24 for Cohort 2 and Day 46 for Cohort 4.
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.
3 secondary outcomes
Number of Participants With Skin Irritation at the Application Site Assessed Using the Predefined Skin Reaction Score
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM1001 Transdermal Patch and Pramipexole Extended-Release Tablet in people with Healthy Participants, run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, or Adverse Events Leading to Study Withdrawal (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.). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.