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A Single-Dose Study of LY3471851 in Healthy Participants

A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04998487
Enrollment
71
Registered
2021-08-10
Start date
2021-08-16
Completion date
2022-07-06
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

Administered SC.

Sponsors

Eli Lilly and Company
CollaboratorINDUSTRY
Nektar Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851Predose up to 56 days postdosePK: Cmax of LY3471851
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851Predose up to 56 days postdosePK: AUC of LY3471851

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026