Peresolimab Bioavailability in Healthy Subjects

Recruiting at 1 trial location

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Biologics, Live vaccines

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

57 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been treated with biologic agents or received a live vaccine recently, you may not be eligible to participate.

What is the purpose of this trial?

This trial tests peresolimab, a drug, to see how it moves through the body and how long it stays when injected under the skin. Healthy participants are chosen to ensure clear results. The study also checks for safety and any side effects.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for healthy men and women with a BMI of 18.0-32.0 kg/m², weighing at least 45 kg, who have stable vital signs and no recent infections or significant health issues. Participants must not be able to bear children or agree to use contraception, and should not have had cancer (with some exceptions) in the past 5 years.

Inclusion Criteria

Male and female participants with verified good health as evidenced by medical records, physical examination, and other screening protocols.

Male participants must commit to utilizing effective contraceptive measures and females who are unable to conceive a child.

You must weigh 45 kilograms or more, and have a BMI between 18.0 kg/m² and 32.0 kg/m² at the time of screening to be eligible for this study.

Exclusion Criteria

Have a current or recent acute, active infection. For at least 30 days before screening and up to the baseline visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment

Have active TB

Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study intervention, or of interfering with the interpretation of data

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of peresolimab to assess bioavailability and tolerability

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics, including maximum concentration and area under the curve measurements

12 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Peresolimab

Trial Overview The study tests how different formulations of Peresolimab are absorbed and processed by the body when injected under the skin compared to a reference formulation. It also assesses safety and side effects over approximately 17 weeks including screening time.

Participant Groups

Group I: Peresolimab (Test 3) Experimental Treatment 1 Intervention

Peresolimab administered SC.

Group II: Peresolimab (Test 2) Experimental Treatment 1 Intervention

Peresolimab administered SC.

Group III: Peresolimab (Test 1) Experimental Treatment 1 Intervention

Peresolimab administered subcutaneously (SC).

Group IV: Peresolimab (Reference) Experimental Treatment 1 Intervention

Peresolimab administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University