Trial · NCT04441931
A Study of LY3832479 (LY-CoV016) in Healthy Participants
NCT04441931, Phase 1, Completed, Eli Lilly and Company; results first posted 2021-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of LY3832479 (LY-CoV016) in Healthy Participants. Trials, record NCT04441931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04441931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY3832479 (LY-CoV016) in Healthy Participants
- NCT number
- NCT04441931
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Healthy
- Interventions
- LY3832479, Placebo
- First posted
- 2020-06-22
- Last updated
- 2021-12-06
- Results first posted
- 2021-12-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Follow-up (Week 12) | The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC\[0-∞\]) of LY3832479. |
| Secondary | PK: Maximum Serum Concentration (Cmax) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | PK: Maximum Serum Concentration (Cmax) of LY3832479. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Follow-up (Week 12) | All randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | All randomized participants who received at least one dose of study drug and had evaluable PK data. | micrograms*day per milliliter(ug*day/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Maximum Serum Concentration (Cmax) of LY3832479 | Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 | All randomized participants who received at least one dose of study drug and had evaluable PK data. | ug/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Pooled Placebo | 0 | Participants | ||
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 700 mg LY3832479 IV | 0 | Participants | ||
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 2800 mg LY3832479 IV | 0 | Participants | ||
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | 7000 mg LY3832479 IV | 0 | Participants | ||
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 700 mg LY3832479 IV | 4920 | Geometric Coefficient of Variation 23 | micrograms*day per milliliter(ug*day/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 2800 mg LY3832479 IV | 22700 | Geometric Coefficient of Variation 22 | micrograms*day per milliliter(ug*day/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 | 7000 mg LY3832479 IV | 50800 | Geometric Coefficient of Variation 33 | micrograms*day per milliliter(ug*day/mL) | |
| PK: Maximum Serum Concentration (Cmax) of LY3832479 | 700 mg LY3832479 IV | 244 | Geometric Coefficient of Variation 24 | ug/mL | |
| PK: Maximum Serum Concentration (Cmax) of LY3832479 | 2800 mg LY3832479 IV | 1130 | Geometric Coefficient of Variation 14 | ug/mL | |
| PK: Maximum Serum Concentration (Cmax) of LY3832479 | 7000 mg LY3832479 IV | 2390 | Geometric Coefficient of Variation 23 | ug/mL |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pooled Placebo | 6 | |
| Overall Study | STARTED | 700 mg LY3832479 IV | 7 | |
| Overall Study | STARTED | 2800 mg LY3832479 IV | 7 | |
| Overall Study | STARTED | 7000 mg LY3832479 IV | 6 | |
| Overall Study | Received at Least One Dose of Study Drug | Pooled Placebo | 6 | |
| Overall Study | Received at Least One Dose of Study Drug | 700 mg LY3832479 IV | 7 | |
| Overall Study | Received at Least One Dose of Study Drug | 2800 mg LY3832479 IV | 7 | |
| Overall Study | Received at Least One Dose of Study Drug | 7000 mg LY3832479 IV | 6 | |
| Overall Study | COMPLETED | Pooled Placebo | 6 | |
| Overall Study | COMPLETED | 700 mg LY3832479 IV | 7 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Pooled Placebo IV | 1 | 6 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | 700 mg LY3832479 IV | 0 | 7 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | 2800 mg LY3832479 IV | 0 | 7 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | 7000 mg LY3832479 IV | 0 | 6 | 0 |
| other | Covid-19 | Infections and infestations | Pooled Placebo IV | 1 | 6 | 1 |
| other | Covid-19 | Infections and infestations | 700 mg LY3832479 IV | 0 | 7 | 0 |
| other | Covid-19 | Infections and infestations | 2800 mg LY3832479 IV | 0 | 7 | 0 |
| other | Covid-19 | Infections and infestations | 7000 mg LY3832479 IV | 0 | 6 | 0 |
| other | Arthropod sting | Injury, poisoning and procedural complications | Pooled Placebo IV | 1 | 6 | 1 |
| other | Arthropod sting | Injury, poisoning and procedural complications | 700 mg LY3832479 IV | 0 | 7 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pooled Placebo IV | 0 | 6 |
| Total, all-cause mortality | 700 mg LY3832479 IV | 0 | 7 |
| Total, all-cause mortality | 2800 mg LY3832479 IV | 0 | 7 |
| Total, all-cause mortality | 7000 mg LY3832479 IV | 0 | 6 |
| Total, other adverse events | Pooled Placebo IV | 3 | 6 |
| Total, other adverse events | 700 mg LY3832479 IV | 2 | 7 |
| Total, other adverse events | 2800 mg LY3832479 IV | 2 | 7 |
| Total, other adverse events | 7000 mg LY3832479 IV | 0 | 6 |
| Total, serious adverse events | Pooled Placebo IV | 0 | 6 |
| Total, serious adverse events | 700 mg LY3832479 IV | 0 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34473343 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04441931
GET https://conductscience.org/api/trials/v1/NCT04441931/events?page=2