A Study Investigating Lu AG22515 in Healthy Adults

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136053
• Other study ID #: 20119A
• Secondary ID: APB-A1-101
• Status: Completed
• Phase: Phase 1
• Start date: March 18, 2022
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Other known NCT identifiers

• NCT05303246

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 5, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AG22515
sterile solution for infusion
• Placebo
sterile solution for infusion
• Immune System Activator
sterile powder for injection

Locations

Country	Name	City	State
United States	CenExel CNS	Long Beach	California
United States	Frontage Clinical Research Inc	Secaucus	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)