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New Parkinson's drug candidate PDM608 begins first human safety tests

NCT ID NCT05950906

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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