A Study Investigating Lu AG22515 in Healthy Adults
Status and phase
Completed
Phase 1
Conditions
Healthy Participants
Treatments
Drug: Placebo
Drug: Immune System Activator
Drug: Lu AG22515
Details and patient eligibility
About
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).
Enrollment
58 patients
Sex
All
Ages
19 to 60 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Double Blind
58 participants in 6 patient groups, including a placebo group
Part A: Lu AG22515
Experimental group
Description:
Participants will receive a single intravenous (IV) infusion of Lu AG22515.
Treatment:
Drug: Lu AG22515
Part A: Placebo
Placebo Comparator group
Description:
Participants will receive a single IV infusion of placebo matching to Lu AG22515.
Treatment:
Drug: Placebo
Part B: Lu AG22515 and Immune System Activator
Experimental group
Description:
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.
Treatment:
Drug: Lu AG22515
Drug: Immune System Activator
Part B: Placebo and Immune System Activator
Placebo Comparator group
Description:
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.
Treatment:
Drug: Immune System Activator
Drug: Placebo
Part C: Lu AG22515
Experimental group
Description:
Participants will receive a single intravenous (IV) infusion of Lu AG22515.
Treatment:
Drug: Lu AG22515
Part C: Placebo
Placebo Comparator group
Description:
Participants will receive a single IV infusion of placebo matching to Lu AG22515.
Treatment:
Drug: Placebo
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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