A Study of LY3200327 in Healthy Participants
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects
2 other identifiers
interventional
52
1 country
1
Brief Summary
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body. The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2015
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedSeptember 12, 2016
September 1, 2016
9 months
November 2, 2015
September 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to study completion (approximately 12 weeks)
Secondary Outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327
Pre-dose up to 84 days post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327
Pre-dose up to 84 days post dose
Study Arms (4)
Placebo (SC)
PLACEBO COMPARATORSingle subcutaneous (SC) dose of placebo
LY3200327 (SC)
EXPERIMENTALSingle escalating subcutaneous (SC) dose of LY3200327
LY3200327 (IV)
EXPERIMENTALSingle intravenous (IV) dose of LY3200327
Placebo (IV)
PLACEBO COMPARATORSingle intravenous (IV) dose of placebo
Interventions
Eligibility Criteria
You may qualify if:
- At the time of initial screening, in general good health
- First-generation healthy Japanese (age 20 to 65 years) will be included
You may not qualify if:
- Pregnancy or breastfeeding during the study
- Chronic infection
- Treatment with prohibited medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International/ California Clinical Trials
Glendale, California, 91206, United States
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 3, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
September 12, 2016
Record last verified: 2016-09