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

NCT07513441 | Recruiting Phase 1

• 1 other identifier: 20501A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

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

  Up to 60 days

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

  Days 1, 21 or 31, and 41

• Maximum Observed Plasma Concentration (Cmax) of Lu AF28996

  Days 1, 21 or 31, and 41

• Time to Reach Cmax (Tmax) of Lu AF28996

  Days 1, 21 or 31, and 41

Study Arms (1)

Lu AF28996

EXPERIMENTAL

Participants will receive oral doses of Lu AF28996 twice daily (BID) as add-on to the participant's usual PD treatment (levodopa and allowed PD medications) during the Up-titration treatment period, whereafter the participants will initiate down-titration of Lu AF28996.

Drug: Lu AF28996

Interventions

Lu AF28996 DRUG

Capsule administered orally per schedule specified in the arm description.

Lu AF28996

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (4)

Beijing TiantanHospital, CapitalMedical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Fudan University - Huashan Hospital - Institute of Urology

Shanghai Shi, Shanghai Municipality, 200040, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Central Study Contacts

Email contact via H. Lundbeck A/S

CONTACT

+45 36301311; HQ_Medinfo@Lundbeck.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

CN (4)