HealthyPhase 1NCT04611789

A Study of LY3832479 (LY-CoV016) in Healthy Participants 1

A Phase 1 study testing LY3832479 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 LY3832479 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3832479 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?: LY3832479
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2020to 10 Feb 2021
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 LY3832479 Administered Subcutaneously to Healthy Participants

Conditions: Healthy
Being tested: LY3832479, Placebo

What participants receive

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

LY3832479Drug
Also called LY-CoV016, Etesevimab
Administered subcutaneously
PlaceboDrug
Administered subcutaneously

Study groups in NCT04611789
Study group	Role	What they receive
LY3832479	Experimental	Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479. Receives: Drug: LY3832479
Placebo	Placebo comparator	Participants received single subcutaneous 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 0 to Tlast (AUC[0-tlast]) of LY3832479
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC[0-tlast]) of LY3832479.
Measured: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
PK: Maximum Serum Concentration (Cmax) of LY3832479
PK: Maximum Serum Concentration (Cmax) of LY3832479.
Measured: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose

Timeline

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

2 Nov 202010 Feb 2021

First posted2 Nov 2020
Study start2 Nov 2020
Primary completion10 Feb 2021
Study completion10 Feb 2021

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.
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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04611789
Sponsor's protocol ID: 18154
Other IDs: J2Z-MC-PGAB
Status last verified: Nov 2021
First submitted: 30 Oct 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

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 LY3832479 Administered Subcutaneously to Healthy Participants
ClinicalTrials.gov ID: NCT04611789
Acronym / sponsor ID: 18154
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Shanghai Junshi Bioscience Co., Ltd.
Study start: 2 Nov 2020 (actual)
Primary completion: 10 Feb 2021 (actual)
Study completion: 10 Feb 2021 (actual)
First posted: 2 Nov 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
LY3832479	Experimental	Drug: LY3832479Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479.
Placebo	Placebo comparator	Drug: PlaceboParticipants received single subcutaneous 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
LY3832479Also: LY-CoV016, EtesevimabAdministered subcutaneously	Drug	LY3832479
PlaceboAdministered subcutaneously	Drug	Placebo

Primary outcome

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC[0-tlast]) of LY3832479.
PK: Maximum Serum Concentration (Cmax) of LY3832479
Time frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
PK: Maximum Serum Concentration (Cmax) of LY3832479.

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	4	3
350 mg LY3832479	7	7
1000 mg LY3832479	7	7

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479

Time frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose. Geometric mean (Geometric Coefficient of Variation). Unit: microgram*day per milliliter (μg*day/mL)

Measure	350 mg LY3832479 n = 7	1000 mg LY3832479 n = 7
Value	1560 (80)	4530 (31)

Population analysed: All randomized participants who received study drug and had evaluable PK data.

Primary outcome: PK: Maximum Serum Concentration (Cmax) of LY3832479

Time frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose. Geometric mean (Geometric Coefficient of Variation). Unit: μg/mL

Measure	350 mg LY3832479 n = 7	1000 mg LY3832479 n = 7
Value	39.1 (39)	91.9 (35)

Population analysed: All randomized participants who received study drug and had evaluable PK data.

Adverse events

Time frame: Baseline, upto 3 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC	0 of 4 (0%)	0 of 4 (0%)	0 of 4
350 mg LY3832479 SC	0 of 7 (0%)	0 of 7 (0%)	0 of 7
1000 mg LY3832479 SC	0 of 7 (0%)	1 of 7 (14.3%)	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.
Individual participant dataSharing planned: No

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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 LY3832479 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 0 to Tlast (AUC[0-tlast]) of LY3832479 (time frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose). The study lists 2 primary outcomes in all. 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 NCT04611789.

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.