Parkinson's drug WD-1603: does timing matter?
NCT ID NCT07442591
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study is testing how the body handles WD-1603, a combination of carbidopa and levodopa used for Parkinson's disease, when taken at different time intervals. Twelve healthy adults will take the drug twice a day on three separate days, with gaps of 5, 6, or 7 hours between doses. Researchers will measure drug levels in the blood and check for side effects to find the best dosing schedule.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carbidopa and levodopa controlled-release tablets
- What this could lead to
- If successful, this study could help determine the best dosing schedule for WD-1603, potentially improving treatment for Parkinson's disease.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. Results may not predict effects in people with Parkinson's, and the drug may still cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy adult male or female participants aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF). * Body weight: male ≥ 50 kg, female ≥ 45 kg; body mass index (BMI) between 18 and 27 kg/m² (inclusive) (BMI = weight \[kg\] / height² \[m²\]). * Medical history inquiry, physical examination, vital signs, laboratory tests (complete blood count, urinalysis, blood biochemistry, serological virology tests, coagulation function), 12-lead ECG, intraocular pressure measurement, abdominal ultrasound, and chest X-ray during the screening period are all within normal ranges or clinically insignificant if outside normal ranges. * Participants (including their spouses or partners) have no plans for conception or for donating sperm/eggs from the time of signing the ICF (for females)/first dosing (for males) until 3 months after the last dose, and voluntarily agree to use effective non-pharmacological contraception during the trial period. * Fully understand the trial content, procedures, and potential adverse reactions, voluntarily agree to participate, and sign the ICF before any trial-related procedures begin. * Able to communicate well with the investigators and capable of understanding and complying with the requirements of this trial. Exclusion Criteria: * Allergy-prone constitution, history of allergic diseases, or known severe allergic reaction or allergy history to levodopa/carbidopa or related medications. * Drug use within 3 months prior to screening, history of drug abuse, or positive urine drug abuse screening (morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine). * History of glaucoma, cancer, diabetes mellitus, bronchial asthma, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, endocrine, neuropsychiatric diseases, or other significant conditions. * Dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy), or gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome. * History of orthostatic hypotension. * Any relevant medical history, surgical history, or trauma within 3 months prior to the first dose that may affect trial safety or drug pharmacokinetics, or planned surgery during the trial period. * Use of prescription drugs, over-the-counter medications, health products, Chinese herbal medicines, or dietary supplements within 4 weeks prior to the first dose, especially monoamine oxidase inhibitors (e.g., phenelzine, rasagiline, selegiline, brofaromine, toloxatone, isocarboxazid, etc.). * Participation in any clinical trial and receipt of investigational drugs within 3 months prior to the first dose. * Blood donation (including component blood) or significant blood loss (≥400 mL), blood transfusion, or use of blood products within 3 months prior to the first dose. * Difficulty with venous access, unsuitability or unwillingness to use intravenous catheters, or history of needle/blood phobia. * Heavy smokers or average daily cigarette consumption of more than 10 cigarettes within 3 months prior to screening. * Alcohol consumption exceeding 21 standard units per week within 3 months prior to screening (1 standard unit contains 14g of alcohol, e.g., 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine), positive alcohol breath test, or unwillingness to abstain from alcohol from 48 hours before the first dose of each period until the completion of blood sampling for that period. * Estimated glomerular filtration rate (eGFR) \< 90 mL/min·1.73m² during the screening period. * During screening: systolic blood pressure \< 90 mmHg or ≥ 140 mmHg, diastolic blood pressure \< 60 mmHg or ≥ 90 mmHg, pulse rate \> 100 beats/min or \< 50 beats/min. * History of prolonged QT interval or other clinically significant cardiac diseases, or QTcF ≥ 450 ms on ECG during screening. * Symptoms of acute infection (e.g., influenza) or acute gastroenteritis within 2 weeks prior to screening, or history of vomiting or diarrhea within 1 week prior to screening. * Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody. * Currently pregnant (including positive pregnancy test) or lactating female. * Poor compliance as judged by the investigator, or other factors deemed unsuitable for participation in this trial.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Xuhui Central Hospital
RECRUITINGShanghai, China
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