Peresolimab Bioavailability in Healthy Subjects

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how much of the experimental drug peresolimab enters the bloodstream and how quickly the body eliminates it when administered under the skin. The study also examines any side effects and evaluates the drug's safety and tolerability. It targets healthy individuals without significant health issues, such as heart or liver problems, and without a history of severe allergies or infections. Participants will be involved for about 17 weeks, including screening. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that peresolimab is likely to be safe for humans?

Research has shown that peresolimab has been tested in people with rheumatoid arthritis, and results indicate it is generally well-tolerated. In one study with adults, most participants managed the treatment without major issues. However, like any medication, some experienced side effects, mostly mild, such as headaches or stomach discomfort.

Since this trial involves healthy participants and peresolimab remains under study, understanding that the complete safety profile is still being established is important. The trial aims to learn how peresolimab works in the body, which is crucial for confirming its safety. For those considering joining this trial, knowing that previous studies have shown mild side effects might be reassuring, but staying informed and discussing any concerns with the study team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Peresolimab because it represents a novel approach to treating autoimmune conditions. Unlike traditional treatments that broadly suppress the immune system, Peresolimab specifically targets the PD-1 pathway, which plays a crucial role in immune regulation. This targeted action could potentially reduce unwanted side effects and improve patient outcomes by modulating the immune system more precisely. Additionally, Peresolimab is administered subcutaneously, which might offer a more convenient and less invasive option compared to some current therapies that require intravenous infusion.

What evidence suggests that this trial's treatments could be effective?

Research has shown that peresolimab may help treat rheumatoid arthritis. One study found it more effective than a placebo in improving symptoms by week 12. This suggests that the drug stimulates the PD-1 receptor, a protein that helps control immune responses, which could be beneficial. The study also indicated that the safety of peresolimab was similar to that of the placebo, suggesting it is generally safe. These results support further research into its effectiveness for other conditions. ^{2 3 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05959109

Study Details | NCT05959109 | A Relative Bioavailability ... Study Overview. The main purpose of this study is to look at the amount of the study drug, peresolimab, that gets into the blood stream and how long it takes ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-6-2023-8e518

Peresolimab Bioavailability in Healthy Subjects 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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209856

A Phase 2 Trial of Peresolimab for Adults with Rheumatoid ... Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis. These results provide evidence that stimulation of the PD-1 receptor has ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05516758

NCT05516758 | A Study of Peresolimab (LY3462817) in ... The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis ...

5. sigma.larvol.com sigma.larvol.com/product.php?e1=811950&tab=newstrac

peresolimab (LY3462817) News Peresolimab was superior to placebo at Week 12 for several key endpoints. Safety events were similar between treatment groups. |||||||||| peresolimab (LY3462817) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9734218/

Results from Phase I Clinical Studies Here, we present data from five phase I clinical studies describing the pharmacokinetics, immunogenicity and safety of spesolimab at escalating ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761244s000lbl.pdf

SPEVIGO® (spesolimab-sbzo) injection, for intravenous use There are limited data on the impact of ADAs on safety and efficacy upon retreatment as the majority of subjects did not experience a subsequent, new flare in ...