Phase 1 N=41 Randomized Double-blind Basic Science

A Study of LY3025876 in Healthy Volunteers

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01528124 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events — 0; 0; 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: LY3025876 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events	0; 0; 0; 0; 0; 0	—
SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876	NA; 62.5; 180; 595; 1920; 3780	—
SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876	1.88; 7.25; 16.0; 55.0; 187; 347	—
SECONDARY Number of Participants Developing Anti-LY3025876 Antibodies	0; 0; 0; 0; 0; 0	—

Summary

This trial is conducted in Singapore. The aim of this trial is to evaluate the safety and tolerability of the study drug in healthy people and investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

Eligibility Criteria

Inclusion Criteria

Must be either a healthy male or a healthy female who cannot become pregnant
Have a body mass index (BMI) of 18.5 to 40.0 kilograms per meter squared (kg/m^2), inclusive, at screening

Exclusion Criteria

Are allergic to LY3025876 or related compounds
Have a history of significant disease that may affect the actions of drugs or may pose a risk when taking the study medication
Have a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids. Corticosteroids are mainly used to control inflammation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01528124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.