A Study Investigating Lu AG22515 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2023-08-05

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Lu AG22515

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

Group Type EXPERIMENTAL

Lu AG22515

Intervention Type DRUG

sterile solution for infusion

Part A: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sterile solution for infusion

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.

Group Type EXPERIMENTAL

Lu AG22515

Intervention Type DRUG

sterile solution for infusion

Immune System Activator

Intervention Type DRUG

sterile powder for injection

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sterile solution for infusion

Immune System Activator

Intervention Type DRUG

sterile powder for injection

Part C: Lu AG22515

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

Group Type EXPERIMENTAL

Lu AG22515

Intervention Type DRUG

sterile solution for infusion

Part C: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sterile solution for infusion

Interventions

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Lu AG22515

sterile solution for infusion

Intervention Type DRUG

Placebo

sterile solution for infusion

Intervention Type DRUG

Immune System Activator

sterile powder for injection

Intervention Type DRUG

Other Intervention Names

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APB-A1

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes