A Study Investigating Lu AG22515 in Healthy Adults

NCT05136053 | Completed Phase 1 FDA Drug

• 2 other identifiers: 20119AAPB-A1-101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

Study Arms (6)

Part A: Lu AG22515

EXPERIMENTAL

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

Drug: Lu AG22515

Part A: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: Lu AG22515 and Immune System Activator

EXPERIMENTAL

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

Part B: Placebo and Immune System Activator

PLACEBO COMPARATOR

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

Part C: Lu AG22515

EXPERIMENTAL

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

Drug: Lu AG22515

Part C: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lu AG22515 DRUG

sterile solution for infusion

Also known as: APB-A1

Part A: Lu AG22515; Part B: Lu AG22515 and Immune System Activator; Part C: Lu AG22515

Placebo DRUG

sterile solution for infusion

Part A: Placebo; Part B: Placebo and Immune System Activator; Part C: Placebo

Immune System Activator DRUG

sterile powder for injection

Part B: Lu AG22515 and Immune System Activator; Part B: Placebo and Immune System Activator

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (2)

CenExel CNS

Long Beach, California, 90806, United States

Location

Frontage Clinical Research Inc

Secaucus, New Jersey, 07094, United States

Location

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 26, 2021
• Study Start: March 18, 2022
• Primary Completion: August 5, 2023
• Study Completion: August 5, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

US (2)