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

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 the body to get rid of it when given under the skin using test formulations versus reference formulation in healthy participants. The study will also evaluate the safety and tolerability of peresolimab and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Peresolimab

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • LabCorp CRU, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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:

  1. basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  2. 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:

  1. serious (requiring hospitalization, or IV or equivalent oral antibiotic treatment, or both)
  2. opportunistic (as defined in Winthrop et al. 2015)
  3. chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer)
  4. 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peresolimab (Test 1); Peresolimab administered subcutaneously (SC).	Drug: Peresolimab; Administered SC; Other Names: LY3462817
Experimental: Peresolimab (Test 2); Peresolimab administered SC.	Drug: Peresolimab; Administered SC; Other Names: LY3462817
Experimental: Peresolimab (Test 3); Peresolimab administered SC.	Drug: Peresolimab; Administered SC; Other Names: LY3462817
Experimental: Peresolimab (Reference); Peresolimab administered SC.	Drug: Peresolimab; Administered SC; Other Names: LY3462817

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab	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	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	PK: AUC(0-∞) of Peresolimab	Predose up to 85 days postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• 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): July 21, 2023
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No