CompletedNCT04537910Updated Dec 6, 2021Results posted

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

A Phase 1 interventional study of LY3819253 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: 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

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])

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 25 participants (actual)

Study arms

Experimental
LY3819253
Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.
Drug: LY3819253
Placebo comparator
Placebo
Participants received a single SC dose of Placebo.
Drug: Placebo

Interventions

DrugLY3819253
Administered SC.
Also known as: LY-CoV555, Bamlanivimab
DrugPlacebo
Administered SC.

What researchers measure

Primary outcomes

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

Results

Posted Dec 6, 2021

Participant flow

Participant flow — Overall Study
Milestone	Placebo SC	150 Milligram (mg) LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC
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

Outcome measures

PrimaryPharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253

PK: AUC\[0-∞\] of LY3819253

Time frame:: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose
Reported as:: Geometric mean · micrograms*day per milliliter(μg*day/mL)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
microgramsday per milliliter(μgday/mL)	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253	NA ± NA	918 ± 15	1390 ± 34

Adverse events

Collected over Baseline to Follow-up (up to 85 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo SC	0/6 (0%)	0/6 (0%)	2/6 (33.3%)
150 mg LY3819253 SC	0/5 (0%)	0/5 (0%)	2/5 (40%)
350 mg LY3819253 SC	0/7 (0%)	0/7 (0%)	1/7 (14.3%)
700 mg LY3819253 SC	0/7 (0%)	0/7 (0%)	0/7 (0%)

Most frequent other events

Most frequent other events
Event	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC
Faeces discolouredGastrointestinal disorders	0/6	1/5	0/7	0/7
HeadacheNervous system disorders	0/6	1/5	0/7	0/7
Nasal congestionRespiratory, thoracic and mediastinal disorders	0/6	1/5	0/7	0/7
NauseaGastrointestinal disorders	1/6	0/5	0/7	0/7
COVID-19Infections and infestations	1/6	0/5	0/7	0/7
ParaesthesiaNervous system disorders	1/6	0/5	0/7	0/7
Back painMusculoskeletal and connective tissue disorders	0/6	0/5	1/7	0/7

Baseline characteristics

All randomized participants.

Age, Categorical
Age, Categorical(Participants)	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	6	5	7	7	25
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
Mean	47.3 ± 12.8	46.0 ± 16	45.6 ± 9.2	41.4 ± 9.2	44.9 ± 11.2

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
Female	3	1	3	2	9
Male	3	4	4	5	16

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	3	1	4	8
White	6	2	6	3	17
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Placebo SC	150 mg LY3819253 SC	350 mg LY3819253 SC	700 mg LY3819253 SC	Total
United States	6	5	7	7	25

Study locations

1 site

Covance Clinical Research Inc
Daytona Beach, Florida 32117, United States

References and documents

Publications

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗

Study documents

Study protocol · Oct 14, 2020
Statistical analysis plan · Sep 1, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04537910
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Sep 3, 2020
Start date: Sep 2, 2020
Primary completion: Dec 28, 2020
Completion: Dec 28, 2020
Results posted: Dec 6, 2021
Last update: Dec 6, 2021

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Eli Lilly and Company

Start the discussion