A Study Investigating the Movement of Lu AG09222 Into, Through, and Out of the Body of Healthy Caucasian, Chinese, and Japanese Participants

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304910
• Other study ID #: 19825A
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm description.
• Placebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.

Locations

Country	Name	City	State
United States	PAREXEL International	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)		Day 1 (predose) to Day 84
Primary	Maximum Observed Concentration (Cmax) of Lu AG09222		Day 1 (predose) to Day 84
Primary	Apparent Elimination Half-Life (t½) of Lu AG09222		Day 1 (predose) to Day 84
Primary	Time to Maximum Observed Concentration (tmax)		Day 1 (predose) to Day 84
Primary	Apparent Total Clearance (CL/F)		Day 1 (predose) to Day 84
Primary	Apparent Volume of Distribution (Vz/F)		Day 1 (predose) to Day 84
Secondary	Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA])		Day 1 (predose) to Day 84
Secondary	Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)		Day 1 (predose) to Day 84