HealthyPhase 1NCT04537910

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

A Phase 1 study testing LY3819253 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3819253
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2020to 28 Dec 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 14Show fewer

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])

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Inc
Daytona Beach, Florida, 32117

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: LY3819253, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3819253Drug
Also called LY-CoV555, Bamlanivimab
Administered SC.
PlaceboDrug
Administered SC.

Study groups in NCT04537910
Study group	Role	What they receive
LY3819253	Experimental	Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253. Receives: Drug: LY3819253
Placebo	Placebo comparator	Participants received a single SC dose of Placebo. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202028 Dec 2020

First posted3 Sep 2020
Study start2 Sep 2020
Primary completion28 Dec 2020
Study completion28 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04537910
Sponsor's protocol ID: 18124
Other IDs: J2X-MC-PYAG
Status last verified: Nov 2021
First submitted: 1 Sep 2020
Last updated: 6 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04537910
Acronym / sponsor ID: 18124
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 2 Sep 2020 (actual)
Primary completion: 28 Dec 2020 (actual)
Study completion: 28 Dec 2020 (actual)
First posted: 3 Sep 2020 (actual)
Results: Posted 6 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
LY3819253	Experimental	Drug: LY3819253Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a single SC dose of Placebo.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (14 listed)

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
Have significant allergies to humanized monoclonal antibodies (mAbs)
Have any of the following that are clinically significant:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3819253Also: LY-CoV555, BamlanivimabAdministered SC.	Drug	LY3819253
PlaceboAdministered SC.	Drug	Placebo

Primary outcome

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

Results and safety

Results posted to the registry on 6 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo SC	6	6
150 Milligram (mg) LY3819253 SC	5	5
350 mg LY3819253 SC	7	7
700 mg LY3819253 SC	7	7

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

Time frame: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms*day per milliliter(μg*day/mL)

Measure	150 mg LY3819253 SC n = 1	350 mg LY3819253 SC n = 3	700 mg LY3819253 SC n = 3
Value	NA (NA)	918 (15)	1390 (34)

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

Adverse events

Time frame: Baseline to Follow-up (up to 85 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
150 mg LY3819253 SC	0 of 5 (0%)	2 of 5 (40%)	0 of 5
350 mg LY3819253 SC	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
700 mg LY3819253 SC	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34473343Kreuzberger 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.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3819253 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253 (time frame: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04537910, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.