Interventional, Randomized, Open-label, Parallel-group, Single-dose Trial Investigating the Safety, Immunogenicity, Tolerability, and Pharmacokinetic Properties of Lu AF82422 in Healthy Chinese and Caucasian Participants

H. Lundbeck A/S1 site in 1 country24 target enrollmentMarch 18, 2024

ConditionsHealthy Participants

InterventionsLu AF82422

DrugsLu AF82422

Overview

Phase: Phase 1
Intervention: Lu AF82422
Conditions: Healthy Participants
Sponsor: H. Lundbeck A/S
Enrollment: 24
Locations: 1
Primary Endpoint: Cmax: maximum observed plasma concentration of Lu AF82422
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.

Registry

clinicaltrials.gov

Start Date

March 18, 2024

End Date

September 3, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

H. Lundbeck A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For Chinese participants only: The participant is Chinese, defined as having four Chinese grandparents.
•For Caucasian participants only: The participant is Caucasian, defined as having four Caucasian grandparents.
•The participant has a Body Mass Index (BMI) ≥19 and ≤26 kilograms per square meter (kg/m2) at the Screening Visit and at the Baseline Visit.
•The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

•The participant has previously been enrolled in this trial.
•The participant has previously been dosed with Lu AF
•The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
•The participant has taken any investigational medicinal product \<3 months or \<5 half-lives of that product, whichever is longer, prior to administration of the IMP.
•The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
•Other protocol-defined criteria apply.

Arms & Interventions

Lu AF82422 Dose Level 1

Participants will receive a single intravenous (IV) infusion of Lu AF82422

Intervention: Lu AF82422

Lu AF82422 Dose Level 2

Participants will receive a single IV infusion of Lu AF82422

Intervention: Lu AF82422