A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants

NCT05959109 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18608J1A-MC-KDAI
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Peresolimab (Test 1)

EXPERIMENTAL

Peresolimab administered subcutaneously (SC).

Drug: Peresolimab

Peresolimab (Test 2)

EXPERIMENTAL

Peresolimab administered SC.

Drug: Peresolimab

Peresolimab (Test 3)

EXPERIMENTAL

Peresolimab administered SC.

Drug: Peresolimab

Peresolimab (Reference)

EXPERIMENTAL

Peresolimab administered SC.

Drug: Peresolimab

Interventions

Peresolimab DRUG

Administered SC

Also known as: LY3462817

Peresolimab (Reference); Peresolimab (Test 1); Peresolimab (Test 2); Peresolimab (Test 3)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

LabCorp CRU, Inc.

Dallas, Texas, 75247, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: July 21, 2023
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)