A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

NCT ID: NCT06258720

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2024-09-03

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF82422 Dose Level 1

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

Group Type: EXPERIMENTAL

Lu AF82422

Intervention Type: DRUG

Lu AF82422 solution for intravenous infusion

Lu AF82422 Dose Level 2

Participants will receive a single IV infusion of Lu AF82422

Group Type: EXPERIMENTAL

Lu AF82422

Intervention Type: DRUG

Lu AF82422 solution for intravenous infusion

Interventions

Lu AF82422

Lu AF82422 solution for intravenous infusion

Intervention Type: DRUG

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 AF82422.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Zhongshan Hospital Fudan University

Shanghai, , China

Countries

China

Other Identifiers

19728A

Identifier Type: -

Identifier Source: org_study_id