A Study Investigating Lu AG22515 in Healthy Adults

Study Overview
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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).

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Lu AG22515
* Drug: Placebo
* Drug: Immune System Activator


Participation Criteria
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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. Note: Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Lu AG22515<br>Participants will receive a single intravenous (IV) infusion of Lu AG22515. | Drug: Lu AG22515<br>* sterile solution for infusion<br>* Other names: APB-A1;|
| Placebo Comparator: Part A: Placebo<br>Participants will receive a single IV infusion of placebo matching to Lu AG22515. | Drug: Placebo<br>* sterile solution for infusion<br>|
| Experimental: Part B: Lu AG22515 and Immune System Activator<br>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<br>* sterile solution for infusion<br>* Other names: APB-A1;Drug: Immune System Activator<br>* sterile powder for injection<br>|
| Placebo Comparator: Part B: Placebo and Immune System Activator<br>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<br>* sterile solution for infusion<br>Drug: Immune System Activator<br>* sterile powder for injection<br>|
| Experimental: Part C: Lu AG22515<br>Participants will receive a single intravenous (IV) infusion of Lu AG22515. | Drug: Lu AG22515<br>* sterile solution for infusion<br>* Other names: APB-A1;|
| Placebo Comparator: Part C: Placebo<br>Participants will receive a single IV infusion of placebo matching to Lu AG22515. | Drug: Placebo<br>* sterile solution for infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |  | From the day of study drug administration (Day 1) up to end of study (Day 113) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Anti-Drug Antibodies (ADAs) |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Maximum Observed Plasma Concentration (Cmax) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Time to Reach Cmax (Tmax) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Apparent Elimination Half-life (t1/2) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Apparent Total Serum Clearance (CL) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) | 
| Mean Residence Time (MRT) of Lu AG22515 |  | Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113) |