Clinical trial NCT05136053: A Study Investigating Lu AG22515 in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the day of study drug administration (Day 1) up to end of study (Day 113)
Secondary outcomes:
measure: Number of Participants With Anti-Drug Antibodies (ADAs)
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Maximum Observed Plasma Concentration (Cmax) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Time to Reach Cmax (Tmax) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Apparent Elimination Half-life (t1/2) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Apparent Total Serum Clearance (CL) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
measure: Mean Residence Time (MRT) of Lu AG22515
timeFrame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: CenExel CNS
state: California
city: Secaucus
country: United States
facility: Frontage Clinical Research Inc
state: New Jersey
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: