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

NCT05304910 | Completed Phase 1 FDA Drug

• 1 other identifier: 19825A
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (6)

• Area Under the Lu AG09222 Serum Concentration-Time Curve (AUC) From Zero to Infinity (AUC0-inf)

  Day 1 (predose) to Day 84

• Maximum Observed Concentration (Cmax) of Lu AG09222

  Day 1 (predose) to Day 84

• Apparent Elimination Half-Life (t½) of Lu AG09222

  Day 1 (predose) to Day 84

• Time to Maximum Observed Concentration (tmax)

  Day 1 (predose) to Day 84

• Apparent Total Clearance (CL/F)

  Day 1 (predose) to Day 84

• Apparent Volume of Distribution (Vz/F)

  Day 1 (predose) to Day 84

Secondary Outcomes (2)

• Number of Participants With Specific Anti-Lu AG09222 Antibodies (Anti-Drug Antibodies [ADA])

  Day 1 (predose) to Day 84

• Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb)

  Day 1 (predose) to Day 84

Study Arms (3)

Lu AG09222 Low Dose

EXPERIMENTAL

Participants will receive a single dose of Lu AG09222 by subcutaneous (SC) injection on Day 1.

Drug: Lu AG09222

Lu AG09222 High Dose

EXPERIMENTAL

Participants will receive a single dose of Lu AG09222 by SC injection on Day 1.

Drug: Lu AG09222

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo matching LU AG0922 by SC injection on Day 1.

Drug: Placebo

Interventions

Lu AG09222 DRUG

Lu AG09222 will be administered per schedule specified in the arm description.

Lu AG09222 High Dose; Lu AG09222 Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

PAREXEL International

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: March 18, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

US (1)