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OpenTrials
Completed

NCT Number: NCT05136053

A Study Investigating Lu AG22515 in Healthy Adults

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).

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel CNS, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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.

Treatment and study plan

Lu AG22515

Drug

sterile solution for infusion

Other names: APB-A1

Placebo

Drug

sterile solution for infusion

Immune System Activator

Drug

sterile powder for injection

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)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Phase 1, 3-Part, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lu AG22515 (APB-A1) in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2021
Registry last updated
Aug 28, 2023

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.

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