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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
Study Summary
This trial tests the safety, effectiveness, and amount of time it takes for a drug, peresolimab, to be absorbed and leave the body when given under the skin of healthy people. It's up to 17 weeks long.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,618 Previous Clinical Trials
3,201,503 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,697 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Male and female participants with verified good health as evidenced by medical records, physical examination, and other screening protocols.Your immune system is not strong enough to protect you from infections.Male participants must commit to utilizing effective contraceptive measures and females who are unable to conceive a child.You have had severe allergic reactions to a type of medicine called monoclonal antibodies or to the ingredients in the drug. You have also had bad reactions to topical corticosteroids or experienced serious skin conditions after treatment.You have had a serious infection that required hospitalization or strong antibiotics within the past 3 months. You also have chronic or recurring infections that have lasted for 6 weeks or longer.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.You possess normal results from blood pressure, pulse rate, and blood/urine laboratory tests that meet the requirements of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Peresolimab (Test 1)
- Group 2: Peresolimab (Test 3)
- Group 3: Peresolimab (Test 2)
- Group 4: Peresolimab (Reference)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Peresolimab (Test 1) achieved authorization by the FDA?
"As it is a Phase 1 trial, which has limited evidentiary backing for both safety and efficacy, Peresolimab (Test 1) was given a score of one on our team's scale."
Answered by AI
Does the age restriction for this research preclude individuals below 30?
"This study seeks participants aged between 18 and 65. For those under the age of 18, there are 56 alternative clinical trials; while for individuals over 65 years old, 374 options exist."
Answered by AI
Are there any participants being sought for this clinical experiment?
"As per clinical trials.gov, this medical trial is not presently seeking participants. Despite the initial posting on July 19th 2023 and last update occurring two days prior, no enrolment is currently being sought for this study; however, 801 more studies are actively looking to recruit patients at present."
Answered by AI
Who meets the qualifications for participation in this investigation?
"To qualify for this medical research, applicants must be of sound health and lie within the 18 to 65 age range. The total number of enrollees solicited is 56."
Answered by AI
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