A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Lu AF82422

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AF82422 Dose Level 1; Participants will receive a single intravenous (IV) infusion of Lu AF82422	Drug: Lu AF82422; Lu AF82422 solution for intravenous infusion
Experimental: Lu AF82422 Dose Level 2; Participants will receive a single IV infusion of Lu AF82422	Drug: Lu AF82422; Lu AF82422 solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-emergent adverse events (safety and tolerability)	Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)	From Day 1 to Day 140
Number of participants with anti-drug antibodies		From Day 1 to Day 140
Cmax: maximum observed plasma concentration of Lu AF82422		From Day 1 to Day 140
Tmax: time to maximum observed concentration of Lu AF82422		From Day 1 to Day 140
AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422		From Day 1 to Day 140
AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422		From Day 1 to Day 140
AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422		From Day 1 to Day 140
AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422		From Day 1 to Day 140
t1/2: apparent terminal elimination half-life of Lu AF82422		From Day 1 to Day 140
MRT: mean residence time of Lu AF82422		From Day 1 to Day 140
CL: systemic clearance of Lu AF82422		From Day 1 to Day 140
t1/2eff: effective elimination half-life of Lu AF82422		From Day 1 to Day 140
Vz: apparent volume of distribution of Lu AF82422		From Day 1 to Day 140
Vss: steady-state volume of distribution of Lu AF82422		From Day 1 to Day 140

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): September 5, 2024
• Study Completion (Estimated): September 5, 2024

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Immunogenicity; Tolerability
• Other Study ID Numbers: 19728A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes