- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04178733
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
May 18, 2020 updated by: Eli Lilly and Company
A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants
This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants.
Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it.
Each enrolled participant will receive a single dose of LY3493269 or placebo.
The study will last up to approximately 71 days for each participant, including screening.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 138623
- Lilly Centre for Clinical Pharmacology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Overtly healthy male or a female who cannot get pregnant
- Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for ease of blood sampling
Exclusion Criteria:
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Have been treated with weight loss medications within 3 months of screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3493269 - Subcutaneous (SC)
LY3493269 administered SC.
|
Administered SC
|
Placebo Comparator: Placebo - SC
Placebo administered SC.
|
Administered SC
|
Experimental: LY3493269 - Intravenous (IV)
LY3493269 administered IV.
|
Administered IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline through final follow-up at approximately Day 43
|
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
|
Baseline through final follow-up at approximately Day 43
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269
Time Frame: Baseline through final follow-up at approximately Day 43
|
PK: AUC of LY3493269
|
Baseline through final follow-up at approximately Day 43
|
PK: Maximum Concentration (Cmax) of LY3493269
Time Frame: Baseline through final follow-up at approximately Day 43
|
PK: Cmax of LY3493269
|
Baseline through final follow-up at approximately Day 43
|
PK: Time to Maximum Concentration (Tmax) of LY3493269
Time Frame: Baseline through final follow-up at approximately Day 43
|
PK: Tmax of LY3493269
|
Baseline through final follow-up at approximately Day 43
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2020
Primary Completion (Actual)
May 11, 2020
Study Completion (Actual)
May 11, 2020
Study Registration Dates
First Submitted
November 25, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 26, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 18, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 17452
- J1X-MC-GZHA (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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