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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 day 1 (within 2 hours prior to the start of infusion) up to end of study (day 113)
Awards & highlights

Study Summary

This trial is testing the safety of a drug called Lu AG22515. Participants will receive a single dose of the drug or a placebo, and researchers will observe any effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (within 2 hours prior to the start of infusion) up to end of study (day 113)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (within 2 hours prior to the start of infusion) up to end of study (day 113) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Apparent Elimination Half-life (t1/2) of Lu AG22515
Apparent Total Serum Clearance (CL) of Lu AG22515
Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515
+5 more

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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AprilBio Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
31 Total Patients Enrolled
H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,525 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,282 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being incorporated into the ongoing research?

"Affirmative. Clinialtrials.gov data reveals that this medical trial, which was originally posted on March 18th 2022 is still actively recruiting patients. The study requires 43 participants across 2 sites to continue its research endeavour."

Answered by AI

Is it possible for adults who exceed the age of 45 to partake in this clinical study?

"This clinical trial is seeking participants aged 19 to 60, while there are seperate trials attuned to the needs of people below and above those age ranges. Specifically, 50 studies cater for minors and 373 research projects focus on seniors."

Answered by AI

Is the APB-A1 drug officially sanctioned by the FDA?

"The safety grade of APB-A1 is 1 since this is a Phase 1 clinical trial, which indicates that there's only scant evidence regarding its efficacy and security."

Answered by AI

Would I qualify for participation in this research endeavor?

"This clinical research aims to enroll 43 healthy subjects aged between 19 and 60. To be selected, applicants must meet these criteria."

Answered by AI

Is there still availability for volunteers to join this clinical trial?

"Affirmative. Information found on clinicaltrials.gov suggests that this medical trial is currently recruiting subjects, which began on March 18th 2022 and was most recently updated November 7th of the same year. 43 participants are needed to join from two distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
California
New York
How old are they?
18 - 65
What site did they apply to?
CenExel CNS
Frontage Clinical Services Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Excited to help cutting edge methods of helping people plus the fascinating element of the scientific process.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. CenExel CNS: < 48 hours
  2. Frontage Clinical Services Inc.: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study Investigating Lu AG22515 in Healthy Adults
2022. "A Study Investigating Lu AG22515 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05136053.
~19 spots leftby Apr 2025
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