Skip to main content
OpenTrials
Completed

NCT Number: NCT06258720

A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF82422

Drug

Lu AF82422 solution for intravenous infusion

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (safety and tolerability)

    Time frame: From Day 1 to Day 140

    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)

  2. Number of participants with anti-drug antibodies

    Time frame: From Day 1 to Day 140

  3. Cmax: maximum observed plasma concentration of Lu AF82422

    Time frame: From Day 1 to Day 140

  4. Tmax: time to maximum observed concentration of Lu AF82422

    Time frame: From Day 1 to Day 140

  5. AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422

    Time frame: From Day 1 to Day 140

  6. AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422

    Time frame: From Day 1 to Day 140

  7. AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422

    Time frame: From Day 1 to Day 140

  8. AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422

    Time frame: From Day 1 to Day 140

  9. t1/2: apparent terminal elimination half-life of Lu AF82422

    Time frame: From Day 1 to Day 140

  10. MRT: mean residence time of Lu AF82422

    Time frame: From Day 1 to Day 140

  11. CL: systemic clearance of Lu AF82422

    Time frame: From Day 1 to Day 140

  12. t1/2eff: effective elimination half-life of Lu AF82422

    Time frame: From Day 1 to Day 140

  13. Vz: apparent volume of distribution of Lu AF82422

    Time frame: From Day 1 to Day 140

  14. Vss: steady-state volume of distribution of Lu AF82422

    Time frame: From Day 1 to Day 140

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.