Clinical trial NCT06258720: A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Safety
Immunogenicity
Tolerability
Pharmacokinetics
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (safety and tolerability)
timeFrame: From Day 1 to Day 140
measure: Number of participants with anti-drug antibodies
timeFrame: From Day 1 to Day 140
measure: Cmax: maximum observed plasma concentration of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: Tmax: time to maximum observed concentration of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: t1/2: apparent terminal elimination half-life of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: MRT: mean residence time of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: CL: systemic clearance of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: t1/2eff: effective elimination half-life of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: Vz: apparent volume of distribution of Lu AF82422
timeFrame: From Day 1 to Day 140
measure: Vss: steady-state volume of distribution of Lu AF82422
timeFrame: From Day 1 to Day 140
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: