A Study of LY4005130 in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT06690996
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY4005130 — DRUG
    Administered IV
  • LY4005130 — DRUG
    Administered SC
  • Placebo — DRUG
    Administered IV
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4005130 gets into the bloodstream and how long it takes the body to eliminate it. Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 26 weeks with 14 visits not including screening.

Key Dates

Start date
Nov 8, 2024
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY4005130 Part A (SAD) SC
    A single-ascending dose of LY4005130 administered subcutaneously (SC)
  • Placebo Comparator: Placebo Part A (SAD) SC
    Placebo administered SC
  • Experimental: LY4005130 Part A (SAD) IV
    A single-ascending dose of LY4005130 administered intravenously (IV)
  • Placebo Comparator: Placebo Part A (SAD) IV
    Placebo administered IV
  • Experimental: LY4005130 Part A (SAD) Optional
    A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
  • Placebo Comparator: Placebo Part A (SAD) Optional
    A single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts
  • Experimental: LY4005130 Part B (MAD) IV
    Multiple-ascending doses of LY4005130 administered IV
  • Placebo Comparator: Placebo Part B (MAD) IV
    Placebo administered IV
  • Experimental: LY4005130 Part B (MAD) SC or IV
    Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
  • Placebo Comparator: Placebo Part B (MAD) SC or IV
    Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts
  • Experimental: LY4005130 Part B (MAD) Optional
    Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
  • Placebo Comparator: Placebo Part B (MAD) Optional
    Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts

Primary Outcome Measure

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline to Study Completion (Up to 26 Weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fortrea Clinical Research UnitDallasTexas75247-

Find similar trials in Dallas, TX

By research site
Fortrea Clinical Research Unit· Dallas, TX

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