A Study of LY3848575 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3848575; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05727072

J4F-MC-CYAA (Other Identifier)

18589

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and tolerability of LY3848575 when administered either intravenously or subcutaneously in single ascending or multiple doses in healthy non-Japanese and first generation Japanese participants. The study will also assess how fast LY3848575 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 142 days excluding the screening period of 28 days.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants who are overtly healthy as determined by medical evaluation
• Have body weight of at least 50 kilograms (kg) for males and 40 kg for females, and body mass index of 18 to 30 kilograms per meter squared (kg/m²), inclusive
• For cohorts with Japanese participants: To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Exclusion criteria

• Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Have participated, within the last 3 months, in a clinical study involving an IP.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups, including a placebo group

LY3848575 IV

Experimental group

Description:

Single ascending doses of LY3848575 administered intravenously (IV).

Treatment:

Drug: LY3848575

Drug: LY3848575

Placebo IV

Placebo Comparator group

Description:

Placebo administered IV.

Treatment:

Drug: Placebo

Drug: Placebo

LY3848575 SC

Experimental group

Description:

Multiple doses of LY3848575 administered subcutaneously (SC).

Treatment:

Drug: LY3848575

Drug: LY3848575

Placebo SC

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Drug: Placebo