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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04441931
Recruitment Status : Completed
First Posted : June 22, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: LY3832479
Drug: Placebo
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pooled Placebo 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Hide Arm/Group Description Participants received single Intravenous (IV) dose of Placebo. Participants received single IV dose of 700 mg LY3832479. Participants received single IV dose of 2800 mg LY3832479. Participants received single IV dose of 7000 mg LY3832479.
Period Title: Overall Study
Started 6 7 7 6
Received at Least One Dose of Study Drug 6 7 7 6
Completed 6 7 7 6
Not Completed 0 0 0 0
Arm/Group Title Pooled Placebo 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV Total
Hide Arm/Group Description Participants received single Intravenous (IV) dose of Placebo. Participants received single IV dose of 700 mg LY3832479. Participants received single IV dose of 2800 mg LY3832479. Participants received single IV dose of 7000 mg LY3832479. Total of all reporting groups
Overall Number of Baseline Participants 6 7 7 6 26
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 7 participants 6 participants 26 participants
42.8  (10.8) 41.0  (7.4) 41.4  (11.2) 45.7  (8.9) 42.6  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 7 participants 6 participants 26 participants
Female 1 1 1 0 3
Male 5 6 6 6 23
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 7 participants 6 participants 26 participants
Hispanic or Latino 3 2 5 1 11
Not Hispanic or Latino 3 5 2 5 15
Unknown or Not Reported 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 7 participants 6 participants 26 participants
American Indian or Alaska Native 0 0 0 0 0
Asian 0 0 1 1 2
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 4 2 0 1 7
White 1 5 6 4 16
More than one race 1 0 0 0 1
Unknown or Not Reported 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 7 participants 6 participants 26 participants
6 7 7 6 26
1.Primary Outcome
Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Hide Description 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.
Time Frame Baseline through Follow-up (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Pooled Placebo 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Hide Arm/Group Description:
Participants received single Intravenous (IV) dose of Placebo.
Participants received single IV dose of 700 mg LY3832479.
Participants received single IV dose of 2800 mg LY3832479.
Participants received single IV dose of 7000 mg LY3832479.
Overall Number of Participants Analyzed 6 7 7 6
Measure Type: Number
Unit of Measure: Participants
0 0 0 0
2.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
Hide Description Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC[0-∞]) of LY3832479.
Time Frame Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Hide Arm/Group Description:
Participants received single IV dose of 700 mg LY3832479.
Participants received single IV dose of 2800 mg LY3832479.
Participants received single IV dose of 7000 mg LY3832479.
Overall Number of Participants Analyzed 7 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*day per milliliter(ug*day/mL)
4920
(23%)
22700
(22%)
50800
(33%)
3.Secondary Outcome
Title PK: Maximum Serum Concentration (Cmax) of LY3832479
Hide Description PK: Maximum Serum Concentration (Cmax) of LY3832479.
Time Frame Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK data.
Arm/Group Title 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Hide Arm/Group Description:
Participants received single IV dose of 700 mg LY3832479.
Participants received single IV dose of 2800 mg LY3832479.
Participants received single IV dose of 7000 mg LY3832479.
Overall Number of Participants Analyzed 7 7 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ug/mL
244
(24%)
1130
(14%)
2390
(23%)
Time Frame Baseline, upto 3 Months
Adverse Event Reporting Description All randomized participants who received at least one dose of study drug.
 
Arm/Group Title Pooled Placebo IV 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Hide Arm/Group Description Participants received single Intravenous (IV) dose of Placebo. Participants received single IV dose of 700 mg LY3832479. Participants received single IV dose of 2800 mg LY3832479. Participants received single IV dose of 7000 mg LY3832479.
All-Cause Mortality
Pooled Placebo IV 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/6 (0.00%)    
Hide Serious Adverse Events
Pooled Placebo IV 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pooled Placebo IV 700 mg LY3832479 IV 2800 mg LY3832479 IV 7000 mg LY3832479 IV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      2/7 (28.57%)      2/7 (28.57%)      0/6 (0.00%)    
Gastrointestinal disorders         
Dyspepsia  1  1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations         
Covid-19  1  1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications         
Arthropod sting  1  1/6 (16.67%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0
Investigations         
Sars-cov-2 test positive  1  0/6 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/6 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0
Headache  1  2/6 (33.33%)  2 1/7 (14.29%)  2 1/7 (14.29%)  1 0/6 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04441931    
Other Study ID Numbers: 18029
J2Z-MC-PGAA ( Other Identifier: Eli Lilly and Company )
First Submitted: June 19, 2020
First Posted: June 22, 2020
Results First Submitted: November 1, 2021
Results First Posted: December 6, 2021
Last Update Posted: December 6, 2021