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Safety Study of LY3041658 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02148627
Collaborator
(none)
54
Enrollment
2
Locations
3
Arms
31.9
Actual Duration (Months)
27
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.

Protocol amended in January, 2016 to include first generation Japanese participants.

Condition or Disease Intervention/Treatment Phase
  • Drug: LY3041658 (SC)
  • Drug: LY3041658 (IV)
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
Actual Study Start Date :
Jun 16, 2014
Actual Primary Completion Date :
Feb 11, 2017
Actual Study Completion Date :
Feb 11, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3041658 (IV)

Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts.

Drug: LY3041658 (IV)
Administered as slow IV infusion
Experimental: LY3041658 (SC)

Single dose of LY3041658 administered subcutaneously (SC).

Drug: LY3041658 (SC)
Administered SC
Placebo Comparator: Placebo

Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion.

Drug: Placebo
Administered as slow IV infusion

Outcome Measures

Primary Outcome Measures

  1. The Number of Participants with One or More Drug-Related Adverse Events [Baseline to study completion (Day 85)]

Secondary Outcome Measures

  1. Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658 [Predose through Day 85, at specified timepoints]

  2. Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast) [Predose through Day 85, at specified timepoints]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • All:

  • Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).

  • Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10^3/microliter (uL), inclusive.

  • First-generation Japanese:

  • Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.

  • Are 20 to 65 years of age, inclusive, at the time of initial screening.

Exclusion Criteria:
  • Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel Early Phase Unit at Glendale Glendale California United States 90216
2 PAREXEL-Phase 1 Baltimore Harbor Hospital Center Baltimore Maryland United States 21225

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02148627
Other Study ID Numbers:
  • 15164
  • I7P-MC-DSAA
First Posted:
May 28, 2014
Last Update Posted:
Feb 15, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Eli Lilly and Company
antibody
autoimmune

Study Results

No Results Posted as of Feb 15, 2017