A Study of LY3478006 in Healthy Participants

NCT04230122 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 17458J2F-MC-OHAA
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

  Baseline through study completion (up to 109 days)

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3478006

  Predose; Day 1 with end of infusion, 3, 6, 12 hours

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of LY3478006

  Predose; Day 1 with end of infusion, 3, 6, 12 hours; Day 2; Day 3; Day 5; Day 8; Day 10; Day 15; Day 22; Day 29; Day 43; Day 57; Day 71 and Day 85

Study Arms (4)

10 milligram (mg) LY3478006 - Intravenous (IV)

EXPERIMENTAL

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.

Drug: LY3478006 - IV

Placebo - IV

PLACEBO COMPARATOR

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.

Drug: Placebo - IV

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

EXPERIMENTAL

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.

Drug: LY3478006 - SC

Placebo - SC (Cohort 7)

PLACEBO COMPARATOR

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.

Drug: Placebo - SC

Interventions

LY3478006 - IV DRUG

Administered IV

10 milligram (mg) LY3478006 - Intravenous (IV)

LY3478006 - SC DRUG

Administered SC

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

Placebo - IV DRUG

Administered IV

Placebo - IV

Placebo - SC DRUG

Administered SC

Placebo - SC (Cohort 7)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

Limitations and Caveats

Cohort 2 through 7 were not explored as study was terminated early for safety reasons after Cohort 1.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: February 17, 2020
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)