A Study Investigating Lu AG22515 in Healthy Adults

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Lu AG22515; Drug: Placebo; Drug: Immune System Activator

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): August 5, 2023
• Study Completion (Actual): August 5, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20119A; APB-A1-101 (Other Identifier: AprilBio Co.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No