A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of Participants With Clinically Significant Adverse Effects
Overview
Brief Summary
The purposes of this study are to evaluate the following in healthy participants: 1) LY2928057 safety, including any side effects possibly associated with LY2928057; 2) how the body processes LY2928057; 3) effect of LY2928057 on blood iron levels; and 4) immune system reactions to LY2928057.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Must either be a healthy male (and willing to use reliable birth control method during the study and for 3 months following last study drug dose), or a healthy female who cannot become pregnant
- •Must have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m\^2), inclusive, and a minimum body weight of 55 kg
- •Must have acceptable blood and urine laboratory test results for the study
- •Must have suitable veins suitable for easy blood collection and study drug administration
- •Must be reliable, follow study procedures, and willing to be available for the duration of the study
- •Must have given written informed consent
- •Must have acceptable blood pressure and pulse rate for the study
Exclusion Criteria
- •Blood test shows that participant has anemia due to lack of iron
- •Currently participating in another clinical study or has completed one less than 30 days ago
- •Allergic to biologic agents
- •Have previously taken part in this study
- •Have abnormal electrocardiogram (ECG) findings that suggest an increased risk with study participation
- •Have a history of significant disease that may affect drug actions or pose risk when taking study medication
- •Have a history of drug or alcohol abuse
- •Are infected with human immunodeficiency virus (HIV)
- •Have hepatitis B
- •Are pregnant or breastfeeding
Arms & Interventions
Placebo
Single intravenous placebo dose.
Intervention: Placebo (Drug)
30 mg LY2928057 (Cohort 1)
Day 1: single 30-milligram (mg) LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
Intervention: LY2928057 (Drug)
100 mg LY2928057 (Cohort 2)
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
Intervention: LY2928057 (Drug)
300 mg LY2928057 (Cohort 3)
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
Intervention: LY2928057 (Drug)
1000 mg LY2928057 (Cohort 4)
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
Intervention: LY2928057 (Drug)
Outcomes
Primary Outcomes
Number of Participants With Clinically Significant Adverse Effects
Time Frame: Baseline through Day 85
A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.
Secondary Outcomes
- Pharmacokinetics, Area Under the Curve (AUC)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Maximum Concentration (Cmax)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Change From Baseline in Serum Iron(Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22)
- Number of Participants Forming Antibody to LY2928057(Baseline through Day 85)
- Pharmacokinetics, Time to Maximum Concentration (Tmax)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Systemic Clearance (CL)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Volume of Distribution (V)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)
- Pharmacokinetics, Terminal Half-Life (t1/2)(Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85)