A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06258720
• Other study ID #: 19728A
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 18, 2024
• Est. completion date: September 5, 2024

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 5, 2024
• Est. primary completion date: September 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AF82422
Lu AF82422 solution for intravenous infusion

Locations

Country	Name	City	State
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with anti-drug antibodies		From Day 1 to Day 140
Primary	Cmax: maximum observed plasma concentration of Lu AF82422		From Day 1 to Day 140
Primary	Tmax: time to maximum observed concentration of Lu AF82422		From Day 1 to Day 140
Primary	AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422		From Day 1 to Day 140
Primary	AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422		From Day 1 to Day 140
Primary	AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422		From Day 1 to Day 140
Primary	AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422		From Day 1 to Day 140
Primary	t1/2: apparent terminal elimination half-life of Lu AF82422		From Day 1 to Day 140
Primary	MRT: mean residence time of Lu AF82422		From Day 1 to Day 140
Primary	CL: systemic clearance of Lu AF82422		From Day 1 to Day 140
Primary	t1/2eff: effective elimination half-life of Lu AF82422		From Day 1 to Day 140
Primary	Vz: apparent volume of distribution of Lu AF82422		From Day 1 to Day 140
Primary	Vss: steady-state volume of distribution of Lu AF82422		From Day 1 to Day 140