Clinical trial NCT05304910: A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Single-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Properties of Lu AG09222 in Healthy Caucasian, Chinese and Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of the study is to learn more about how the body absorbs and eliminates Lu AG09222 after a single dose is injected under the skin. Researchers will also investigate safety and tolerability effects of Lu AG09222 after administration.


Eligibility criteria: Inclusion Criteria:

* The participant is Japanese, defined as having 4 Japanese grandparents, or the participant is Caucasian, or the participant is Chinese, defined as having 4 Chinese grandparents.
* The participant has a body mass index (BMI) ≥18 and ≤28 kilograms (kg)/square meter (m\^2) at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of investigational medicinal product (IMP).
* The participant has had major surgery (excluding laparoscopic cholecystectomy or uncomplicated appendectomy) \<6 months prior to the first dose of IMP.
* The participant has previously been dosed with Lu AG09222.
* The participant has a history of severe drug allergy or hypersensitivity.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)
timeFrame: Day 1 (predose) to Day 84
measure: Maximum Observed Concentration (Cmax) of Lu AG09222
timeFrame: Day 1 (predose) to Day 84
measure: Apparent Elimination Half-Life (t½) of Lu AG09222
timeFrame: Day 1 (predose) to Day 84
measure: Time to Maximum Observed Concentration (tmax)
timeFrame: Day 1 (predose) to Day 84
measure: Apparent Total Clearance (CL/F)
timeFrame: Day 1 (predose) to Day 84
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Day 1 (predose) to Day 84
Secondary outcomes:
measure: Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA])
timeFrame: Day 1 (predose) to Day 84
measure: Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)
timeFrame: Day 1 (predose) to Day 84
Other outcomes:
Locations:
city: Glendale
country: United States
facility: PAREXEL International
state: California
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: