A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Lu AF82422

Study type: Interventional

Funder types: Industry

Identifiers

NCT06258720

19728A

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Lu AF82422 Dose Level 1

Experimental group

Description:

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

Treatment:

Drug: Lu AF82422

Lu AF82422 Dose Level 2

Experimental group

Description:

Participants will receive a single IV infusion of Lu AF82422

Treatment:

Drug: Lu AF82422