ClinicalTrials.gg
RecruitingNCT07513441Updated Aug 10, 2026

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

A Phase 1 interventional study of Lu AF28996 in Parkinson Disease, sponsored by H. Lundbeck A/S. Recruiting at 4 sites in China. Open to participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
35 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Lu AF28996

    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

  • Capsule administered orally per schedule specified in the arm description.

06

What researchers measure

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

07

Study locations

4 of 4 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07513441
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
May 26, 2026
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Email contact via H. Lundbeck A/S
Contact
HQ_Medinfo@Lundbeck.com
+45 36301311
Email contact via H. Lundbeck A/S
study director · LundbeckClinicalTrials@Lundbeck.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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