A Study Investigating Lu AG22515 in Healthy Adults
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT05136053
- Lead Sponsor
- H. Lundbeck A/S
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Lu AG22515 Lu AG22515 Participants will receive a single intravenous (IV) infusion of Lu AG22515. Part A: Placebo Placebo Participants will receive a single IV infusion of placebo matching to Lu AG22515. Part B: Lu AG22515 and Immune System Activator 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. Part B: Placebo and Immune System Activator Placebo 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. Part B: Placebo and Immune System Activator 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. Part B: Lu AG22515 and Immune System Activator Lu AG22515 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. Part C: Placebo Placebo Participants will receive a single IV infusion of placebo matching to Lu AG22515. Part C: Lu AG22515 Lu AG22515 Participants will receive a single intravenous (IV) infusion of Lu AG22515.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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) 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) 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) 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) 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) 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)
Trial Locations
- Locations (2)
Frontage Clinical Research Inc
🇺🇸Secaucus, New Jersey, United States
CenExel CNS
🇺🇸Long Beach, California, United States