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CompletedNCT05136053Updated Aug 28, 2023

A Study Investigating Lu AG22515 in Healthy Adults

A Phase 1 interventional study of Lu AG22515 and Placebo in Healthy Participants, sponsored by H. Lundbeck A/S. Completed at 2 sites in United States. Open to participants aged 19 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.

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

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study summary

The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).

02

Conditions studied

  • Healthy Participants
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
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Body mass index (BMI) ≥18.0 and ≤32.0 kilograms (kg)/square meter (m\^2) and weight between 55 and 110 kg (both inclusive) at screening.
  • Fully vaccinated against COVID-19, as evidenced by presentation of a vaccine card. The last administration of the COVID-19 vaccination must be received a minimum of 30 days and maximum 6 month prior to dosing in this study.
  • Medically healthy with no clinically significant medical history, physical examination and neurological assessment, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.

Part C only:

  • The participant is Japanese, defined as being born in Japan and having four Japanese grandparents as well as living a Japanese lifestyle as confirmed by the Japanese lifestyle questionnaire.

Exclusion criteria

Exclusion Criteria:

  • Reported history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
  • Received any vaccination in the last 30 days prior to Day 1.

Note: Other inclusion and exclusion criteria may apply.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Part A: Lu AG22515

    Participants will receive a single intravenous (IV) infusion of Lu AG22515.

    Drug: Lu AG22515

  • Placebo comparator
    Part A: Placebo

    Participants will receive a single IV infusion of placebo matching to Lu AG22515.

    Drug: Placebo

  • Experimental
    Part B: Lu AG22515 and Immune System Activator

    Participants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion.

    Drug: Lu AG22515 · Drug: Immune System Activator

  • Placebo comparator
    Part B: Placebo and Immune System Activator

    Participants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion.

    Drug: Placebo · Drug: Immune System Activator

  • Experimental
    Part C: Lu AG22515

    Participants will receive a single intravenous (IV) infusion of Lu AG22515.

    Drug: Lu AG22515

  • Placebo comparator
    Part C: Placebo

    Participants will receive a single IV infusion of placebo matching to Lu AG22515.

    Drug: Placebo

Interventions

  • DrugLu AG22515

    sterile solution for infusion

    Also known as: APB-A1

  • DrugPlacebo

    sterile solution for infusion

  • DrugImmune System Activator

    sterile powder for injection

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the day of study drug administration (Day 1) up to end of study (Day 113)

Secondary outcomes

  1. Number of Participants With Anti-Drug Antibodies (ADAs)

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  2. Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  3. Maximum Observed Plasma Concentration (Cmax) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  4. Time to Reach Cmax (Tmax) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  5. Apparent Elimination Half-life (t1/2) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  6. Apparent Total Serum Clearance (CL) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  7. Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

  8. Mean Residence Time (MRT) of Lu AG22515

    Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)

07

Study locations

2 sites
  • CenExel CNS
    Long Beach, California 90806, United States
  • Frontage Clinical Research Inc
    Secaucus, New Jersey 07094, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05136053
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Nov 26, 2021
Start date
Mar 18, 2022
Primary completion
Aug 5, 2023
Completion
Aug 5, 2023
Last update
Aug 28, 2023

Study contacts

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

Oversight

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

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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