A Study of LY3478006 in Healthy Participants

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: LY3478006 - IV; Drug: Placebo - IV; Drug: Placebo - SC; Drug: LY3478006 - SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04230122

17458

J2F-MC-OHAA (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is when given by injection into a vein or just under the skin to healthy participants. Blood tests will be done to check how much LY3478006 is in the bloodstream and how long the body takes to get rid of it. For each participant, the study will last up to about 16 weeks, including screening.

Enrollment: 4 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy male or female Japanese or non-Japanese participants, as determined by medical history and physical examination
• Women not of childbearing potential
• Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at screening

Exclusion criteria

• Have clinically significant abnormal electrocardiogram (ECG) results
• Have persistent abnormal blood pressure or pulse rate, as determined by the investigator
• Have evidence of orthostatic hypotension, defined as a decrease in systolic or diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg) or ≥10 mmHg, respectively
• Have significant history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders
• Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy
• Have significant allergies to humanized monoclonal antibodies

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

4 participants in 4 patient groups, including a placebo group

10 milligram (mg) LY3478006 - Intravenous (IV)

Experimental group

Description:

Participants received single dose of 10 mg LY3478006 administered IV. Due to early termination of the study Cohort 2 to 6 (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg LY3478006 IV) were not explored for safety reasons following dosing of the first 4 participants in Cohort 1.

Treatment:

Drug: LY3478006 - IV

Placebo - IV

Placebo Comparator group

Description:

Participants received single dose of placebo administered IV. Placebo IV Cohorts 2 through 6 were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Treatment:

Drug: Placebo - IV

100 mg LY3478006 - Subcutaneous (SC) (Cohort 7)

Experimental group

Description:

100 mg LY3478006 cohort 7 SC dose was not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Treatment:

Drug: LY3478006 - SC

Placebo - SC (Cohort 7)

Placebo Comparator group

Description:

Placebo cohort 7 SC dose were not explored as study was terminated for safety reasons following dosing of the first 4 participants in cohort 1.

Treatment:

Drug: Placebo - SC