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NCT Number: NCT07513441

A Trial of Lu AF28996 in Participants With Parkinson's Disease (PD)

The purpose of this study is to investigate the safety of Lu AF28996, how well it is tolerated and what the body does to the drug in participants with Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF28996

Drug

Capsule administered orally per schedule specified in the arm description.

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 60 days

  2. Area Under the Plasma Concentration-time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996

    Time frame: Days 1, 21 or 31, and 41

  3. Maximum Observed Plasma Concentration (Cmax) of Lu AF28996

    Time frame: Days 1, 21 or 31, and 41

  4. Time to Reach Cmax (Tmax) of Lu AF28996

    Time frame: Days 1, 21 or 31, and 41

Study contacts

Contact information is provided by the study sponsor or research team.

Email contact via H. Lundbeck A/S

CONTACT

[email protected]

+45 36301311

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Trial Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AF28996 in Chinese Men and Women With Parkinson's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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