What side effects are associated with this type of intervention?

In the study of peresolimab, the focus is on its pharmacokinetics and safety profile in healthy participants. Common side effects for treatments similar to peresolimab, which are often immunomodulatory or immunosuppressive agents, can include mild to moderate reactions such as injection site reactions, fatigue, headache, and gastrointestinal disturbances. Serious adverse events are less common but can include infections due to immune suppression. The study also aims to collect detailed information on any side effects experienced by participants.

What prior FDA approvals exist?

FDA approvals for treatments often focus on specific conditions rather than healthy subjects. However, drugs similar to Peresolimab, which are evaluated for their pharmacokinetics and safety profiles, include various biologics and monoclonal antibodies. These drugs undergo rigorous clinical trials to assess how they are absorbed, distributed, metabolized, and excreted in the body, as well as their safety and tolerability. Examples include monoclonal antibodies like adalimumab and ustekinumab, which have been approved for conditions such as psoriasis and rheumatoid arthritis after thorough pharmacokinetic and safety evaluations in clinical trials.

What other types of research exist?

Promising alternatives to Peresolimab for healthy subjects include PF-06881894, a proposed biosimilar to pegfilgrastim, which has shown pharmacodynamic/pharmacokinetic equivalence and a favorable safety profile in phase 1 trials. Additionally, novel formulations of existing drugs, such as diroximel fumarate for multiple sclerosis, demonstrate improved gastrointestinal tolerability and safety, making them potential alternatives.

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Peresolimab Bioavailability in Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 85 days postdose

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, participants will be monitored for any adverse reactions to Peresolimab which may include typical drug-related intolerances such as injection site reactions, allergies, or systemic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 85 days postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 85 days postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 85 days postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Peresolimab

PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of Peresolimab

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Peresolimab (Test 3)Experimental Treatment1 Intervention

Peresolimab administered SC.

Group II: Peresolimab (Test 2)Experimental Treatment1 Intervention

Peresolimab administered SC.

Group III: Peresolimab (Test 1)Experimental Treatment1 Intervention

Peresolimab administered subcutaneously (SC).

Group IV: Peresolimab (Reference)Experimental Treatment1 Intervention

Peresolimab administered SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peresolimab

2023

Completed Phase 1

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peresolimab, like other biologic agents, works by modulating specific pathways in the immune system to achieve its therapeutic effects. The study of its pharmacokinetics involves understanding how the drug is absorbed into the bloodstream, distributed throughout the body, metabolized by the liver, and eventually excreted. This is crucial for determining the appropriate dosage and frequency to maximize efficacy while minimizing side effects. The safety profile, including any adverse effects, is also evaluated to ensure that the drug is well-tolerated in healthy subjects. Understanding these mechanisms is essential for developing safe and effective treatments, ensuring that they do not cause harm and are beneficial for the intended therapeutic use.

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