A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Nektar Therapeutics
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
Study Overview
Brief Summary
The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overtly healthy males or females, as determined by medical history and physical examination.
- •Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)
Exclusion Criteria
- •Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)
- •Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment
- •Are immunocompromised per investigator judgment.
Arms & Interventions
LY3471851 (Abdomen)
LY3471851 administered subcutaneously (SC) into the abdomen.
Intervention: LY3471851 (Drug)
LY3471851 (Thigh)
LY3471851 administered SC into the thigh.
Intervention: LY3471851 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851
Time Frame: Predose up to 56 days postdose
PK: Cmax of LY3471851
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Time Frame: Predose up to 56 days postdose
PK: AUC of LY3471851
Secondary Outcomes
No secondary outcomes reported