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Completed

NCT Number: NCT05304910

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PAREXEL International

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AG09222

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Day 1 (predose) to Day 84

  2. Maximum Observed Concentration (Cmax) of Lu AG09222

    Time frame: Day 1 (predose) to Day 84

  3. Apparent Elimination Half-Life (t½) of Lu AG09222

    Time frame: Day 1 (predose) to Day 84

  4. Time to Maximum Observed Concentration (tmax)

    Time frame: Day 1 (predose) to Day 84

  5. Apparent Total Clearance (CL/F)

    Time frame: Day 1 (predose) to Day 84

  6. Apparent Volume of Distribution (Vz/F)

    Time frame: Day 1 (predose) to Day 84

Secondary outcomes

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

    Time frame: Day 1 (predose) to Day 84

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

    Time frame: Day 1 (predose) to Day 84

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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