New Parkinson's drug candidate PDM608 begins first human safety tests
NCT ID NCT05950906
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested the safety and tolerability of a new drug called PDM608 in 64 healthy adults. The goal was to see if the drug is safe enough to study further in people with Parkinson's disease. Participants received either PDM608 or a placebo, and researchers monitored for side effects and how the drug moves through the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PDM608
- What this could lead to
- If successful, this could lead to a new treatment option for Parkinson's disease.
- What could go wrong
- This is a very early Phase 1 trial in healthy volunteers, not people with Parkinson's. It only tests safety and dosing, not whether the drug works for the disease.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
64 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
-
Apr 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
-
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 men, or women of non-childbearing potential * Must agree to use an adequate method of contraception * Body mass index (BMI) of 18.0 to 33.0 kg/m2 as measured at screening Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * Significant allergy requiring treatment * History of clinically significant autoimmune, cardiovascular, renal, hepatic, chronic respiratory or GI disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization or surgical procedure within 30 days prior to first dose of study drug or any uncontrolled medical illness as judged by the investigator * Have poor venous access that limits phlebotomy * Evidence of current SARS-CoV-2 infection or exposure to confirmed infection within 10 days prior to the first dose of study drug * Clinically significant abnormal clinical chemistry, hematology or urinalysis * Hepatitis B, Hepatitis C, HIV, TB * Renal impairment * Pregnant or lactating women or men with pregnant or lactating partners * Received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer) * Taking any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT) in the 14 days or 5 half-lives (whichever is longer) before IMP administration * COVID-19 vaccine within 14 days prior to first dose or have a COVID-19 vaccine scheduled between their first dose of IMP and last dose of IMP. * Drug or alcohol abuse in the past 2 years * Regular alcohol consumption in men \>21 units per week and women \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit or 5 oz glass of wine) * Positive alcohol urine test at screening or first admission * Current and within the last six months-smokers, e-cigarettes and nicotine replacement users * Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication * Subjects who are, or are immediate family members of, a study site or Sponsor employee
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Quotient Sciences-Miami, Inc
Miami, Florida, 33126, United States
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Other studies related to the condition(s) this trial covers.
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