A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants
A Phase 1, Single-Dose Study to Assess the Relative Bioavailability and Tolerability of Subcutaneous Peresolimab Test Formulations in Healthy Participants
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 1-317-615-4559
- Email: ClinicalTrials.gov@lilly.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75247
- LabCorp CRU, Inc.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female participants who are overtly healthy as determined by medical history, physical examination, and other screening procedures
- A minimum body weight of 45 kilograms and body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential
Exclusion Criteria:
- 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
- Have a history of allergy to monoclonal antibody therapy or to the excipients in the drug formulation, or have clinically significant intolerance to topical corticosteroids, or a history of severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions:
- basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening.
- Are immunocompromised.
- Have known hypogammaglobulinemia
- 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 had any of the following types of infection within 3 months prior to the screening visit or develops any of these infections before the baseline visit:
- serious (requiring hospitalization, or IV or equivalent oral antibiotic treatment, or both)
- opportunistic (as defined in Winthrop et al. 2015)
- chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer)
- recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).
- Have active TB.
- Have or have had latent tuberculosis infection that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization and the United States Centers for Disease Control and Prevention, unless such treatment is underway.
- Have a current infection with HBV (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA).
- Have a current infection with HCV (that is, positive for HCV RNA).
- Have HIV infection.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Have received any live vaccine (that is, live attenuated) within less than 4 weeks before screening or intend to receive a live vaccine during the study, or within 5 half-lives (8 weeks) after receiving the last dose of study intervention, whichever is longer. Note: The following are not considered live vaccines: RNA vaccines, vaccines with inactive viral elements, and/or nonreplicating viral vector vaccines.
- Have received a bacille Calmette-Guerin vaccination or treatment within less than 4 weeks before screening or intend to receive bacille Calmette-Guerin vaccination or treatment during the study, or within 5 half-lives (8 weeks) after receiving the last dose of study intervention, whichever is longer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Peresolimab (Test 1)
Peresolimab administered subcutaneously (SC).
|
Administered SC
Other Names:
|
|
Experimental: Peresolimab (Test 2)
Peresolimab administered SC.
|
Administered SC
Other Names:
|
|
Experimental: Peresolimab (Test 3)
Peresolimab administered SC.
|
Administered SC
Other Names:
|
|
Experimental: Peresolimab (Reference)
Peresolimab administered SC.
|
Administered SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab
Time Frame: Predose up to 85 days postdose
|
PK: Cmax of Peresolimab
|
Predose up to 85 days postdose
|
|
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of Peresolimab
Time Frame: Predose up to 85 days postdose
|
PK: AUC[0-tlast] of Peresolimab
|
Predose up to 85 days postdose
|
|
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Peresolimab
Time Frame: Predose up to 85 days postdose
|
PK: AUC(0-∞) of Peresolimab
|
Predose up to 85 days postdose
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: 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), Eli Lilly and Company
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 18608
- J1A-MC-KDAI (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.