CClinicalTrials.gg
Sign In
CompletedNCT06258720Updated Nov 12, 2024

A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults

A Phase 1 interventional study of Lu AF82422 in Healthy Participants, sponsored by H. Lundbeck A/S. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2024, 2 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Safety
  • Immunogenicity
  • Tolerability
  • Pharmacokinetics
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Lu AF82422 Dose Level 1

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

    Drug: Lu AF82422

  • Experimental
    Lu AF82422 Dose Level 2

    Participants will receive a single IV infusion of Lu AF82422

    Drug: Lu AF82422

Interventions

  • DrugLu AF82422

    Lu AF82422 solution for intravenous infusion

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: From Day 1 to Day 140

  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

07

Study locations

1 site
  • Zhongshan Hospital Fudan University
    Shanghai, 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06258720
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Mar 18, 2024
Primary completion
Sep 3, 2024
Completion
Sep 3, 2024
Last update
Nov 12, 2024

Study contacts

Email contact via H. Lundbeck A/S
study director · H. Lundbeck A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

H. Lundbeck A/S

Start the discussion