Healthy Participants
Conditions
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).
Interventions
DRUGLu AG22515
sterile solution for infusion
DRUGPlacebo
sterile solution for infusion
DRUGImmune System Activator
sterile powder for injection
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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) |
| 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) |
| 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) |
Countries
United States
Outcome results
None listed