Lu AG22515 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by AprilBio Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new drug called Lu AG22515 to see if it is safe for people to use. Healthy adults will receive either Lu AG22515 or a non-active substance. The study will monitor any side effects or reactions to ensure the drug's safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: Lu AG22515Experimental Treatment1 Intervention

Participants will receive a single intravenous (IV) infusion of Lu AG22515.

Group II: Part B: Lu AG22515 and Immune System ActivatorExperimental Treatment2 Interventions

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.

Group III: Part A: Lu AG22515Experimental Treatment1 Intervention

Participants will receive a single intravenous (IV) infusion of Lu AG22515.

Group IV: Part C: PlaceboPlacebo Group1 Intervention

Participants will receive a single IV infusion of placebo matching to Lu AG22515.

Group V: Part A: PlaceboPlacebo Group1 Intervention

Participants will receive a single IV infusion of placebo matching to Lu AG22515.

Group VI: Part B: Placebo and Immune System ActivatorPlacebo Group2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Lu AG22515

2022

Completed Phase 1

~60

Immune System Activator

2022

Completed Phase 1

~60