New Parkinson's drug candidate enters first safety tests in china
NCT ID NCT07513441
First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This early-stage trial will test the safety and tolerability of a new oral drug called Lu AF28996 in 10 Chinese adults with Parkinson's disease. Participants will take the drug and be monitored for side effects and how the body processes it. The study is not yet recruiting and does not aim to measure whether the drug improves symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lu AF28996 (oral capsule)
- What this could lead to
- If successful, this could lead to a new treatment option to help control Parkinson's symptoms.
- What could go wrong
- This is a very early, small study (10 people) focused only on safety and drug levels, not on effectiveness. Many drugs fail at this stage.
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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2027
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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35 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Key Inclusion Criteria: * The participant is Chinese, defined as having four Chinese grandparents being born in China. * The participant is diagnosed with idiopathic Parkinson's disease (consistent with the United Kingdom PD Society Brain Bank Criteria for the Diagnosis of PD). * The participant's Modified Hoehn and Yahr score is ≥2 and ≤4 (in OFF) and ≤3 in the ON state. * The participant experiences well recognizable and predictable motor fluctuations in the awake time including predictable morning OFF episodes causing clinically significant disability during the last 3 months prior to screening, as evaluated by the investigator. Key Exclusion Criteria: * The participant has received oral or transdermal dopamine agonist treatment ≤4 weeks prior to screening. * The participant has undergone a neurosurgical intervention for Parkinson's disease (such as pallidotomy, thalamotomy, foetal or stem cell transplantation or deep brain stimulation). * The participant has any other disorder for which the treatment takes priority over treatment of Parkinson's disease or is likely to interfere with trial treatment or impair treatment compliance. * The participant has received Traditional Chinese Medicine treatment ≤4 weeks prior to screening. Note: Other protocol-defined inclusion and exclusion criteria may apply.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. 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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Beijing TiantanHospital, CapitalMedical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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Fudan University - Huashan Hospital - Institute of Urology
RECRUITINGShanghai Shi, Shanghai Municipality, 200040, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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Xuanwu Hospital Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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