A Study of LY3819253 (LY-CoV555) in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04537910
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3819253; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3819253 Administered Subcutaneously to Healthy Participants
• Actual Study Start Date: Sep 2, 2020
• Actual Primary Completion Date: Dec 28, 2020
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3819253 Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.	Drug: LY3819253; Administered SC.; Other Names: LY-CoV555 Bamlanivimab
Placebo Comparator: Placebo Participants received a single SC dose of Placebo.	Drug: Placebo; Administered SC.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 [Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose]

   PK: AUC[0-∞] of LY3819253

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation including medical history and physical examination

• Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected

• Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (<)35 kilograms per square meter (kg/m²)

• Male participants must agree to adhere to contraception restrictions

• Female participants must be of non-childbearing potential

Exclusion Criteria:

• Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

• Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of

• Significantly altering the absorption, metabolism, or elimination of drugs

• Constituting a risk while taking the investigational product, or

• Interfering with the interpretation of data

• Have significant allergies to humanized monoclonal antibodies (mAbs)

• Have any of the following that are clinically significant:

• Multiple or severe drug allergies, or

• Intolerance to topical corticosteroids, or

• Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

• Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years

• Have had breast cancer within the past 10 years

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

• Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus [HCV] ribonucleic acid [RNA])

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Inc	Daytona Beach	Florida	United States	32117

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

• Study Protocol - Oct 14, 2020
• Statistical Analysis Plan - Sep 1, 2020

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04537910
• Other Study ID Numbers: 18124; J2X-MC-PYAG
• First Posted: Sep 3, 2020
• Last Update Posted: Dec 6, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Bamlanivimab

Study Results

Participant Flow

Arm/Group Title	Placebo SC	150 Milligram (mg) LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC
Arm/Group Description	Participants received a single subcutaneous (SC) dose of Placebo.	Participants received a single SC dose of 150 mg LY3819253.	Participants received a single SC dose of 350 mg LY3819253.	Participants received a single SC dose of 700 mg LY3819253.
Period Title: Overall Study
STARTED	6	5	7	7
Received at Least One Dose of Study Drug	6	5	7	7
COMPLETED	6	5	7	7
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
Arm/Group Description	Participants received a single SC dose of Placebo.	Participants received a single SC dose of 150 mg LY3819253.	Participants received a single SC dose of 350 mg LY3819253.	Participants received a single SC dose of 700 mg LY3819253.	Total of all reporting groups
Overall Participants	6	5	7	7	25
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	6 100%	5 100%	7 100%	7 100%	25 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.3 (12.8)	46.0 (16)	45.6 (9.2)	41.4 (9.2)	44.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	3 50%	1 20%	3 42.9%	2 28.6%	9 36%
Male	3 50%	4 80%	4 57.1%	5 71.4%	16 64%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	3 60%	1 14.3%	4 57.1%	8 32%
White	6 100%	2 40%	6 85.7%	3 42.9%	17 68%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%	5 100%	7 100%	7 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
Description	PK: AUC[0-∞] of LY3819253
Time Frame	Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of LY3819253 and had evaluable PK data.

Arm/Group Title	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC
Arm/Group Description	Participants received a single SC dose of 150 mg LY3819253.	Participants received a single SC dose of 350 mg LY3819253.	Participants received a single SC dose of 700 mg LY3819253.
Measure Participants	1	3	3
Geometric Mean (Geometric Coefficient of Variation) [micrograms*day per milliliter(μg*day/mL)]	NA (NA)	918 (15)	1390 (34)

Adverse Events

Time Frame	Baseline to Follow-up (up to 85 days)
Adverse Event Reporting Description	All randomized participants who received at least one dose of study drug.
Arm/Group Title	Placebo SC		150 mg LY3819253 SC		350 mg LY3819253 SC		700 mg LY3819253 SC
Arm/Group Description	Participants received a single SC dose of Placebo.		Participants received a single SC dose of 150 mg LY3819253.		Participants received a single SC dose of 350 mg LY3819253.		Participants received a single SC dose of 700 mg LY3819253.
All Cause Mortality
	Placebo SC		150 mg LY3819253 SC		350 mg LY3819253 SC		700 mg LY3819253 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)		0/7 (0%)		0/7 (0%)
Serious Adverse Events
	Placebo SC		150 mg LY3819253 SC		350 mg LY3819253 SC		700 mg LY3819253 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)		0/7 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Placebo SC		150 mg LY3819253 SC		350 mg LY3819253 SC		700 mg LY3819253 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)		2/5 (40%)		1/7 (14.3%)		0/7 (0%)
Gastrointestinal disorders
Faeces discoloured	0/6 (0%)	0	1/5 (20%)	1	0/7 (0%)	0	0/7 (0%)	0
Nausea	1/6 (16.7%)	1	0/5 (0%)	0	0/7 (0%)	0	0/7 (0%)	0
Infections and infestations
COVID-19	1/6 (16.7%)	1	0/5 (0%)	0	0/7 (0%)	0	0/7 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/6 (0%)	0	0/5 (0%)	0	1/7 (14.3%)	1	0/7 (0%)	0
Nervous system disorders
Headache	0/6 (0%)	0	1/5 (20%)	1	0/7 (0%)	0	0/7 (0%)	0
Paraesthesia	1/6 (16.7%)	1	0/5 (0%)	0	0/7 (0%)	0	0/7 (0%)	0
Respiratory, thoracic and mediastinal disorders
Nasal congestion	0/6 (0%)	0	1/5 (20%)	1	0/7 (0%)	0	0/7 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.