A First Human Study of a Ferroportin Antibody

NCT01330953 | Completed Phase 1 Results

• 2 other identifiers: 14151I5M-FW-FABA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Anemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Adverse Effects

  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.

  Baseline through Day 85

Secondary Outcomes (8)

• 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

• 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Single intravenous placebo dose.

Drug: Placebo

30 mg LY2928057 (Cohort 1)

EXPERIMENTAL

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.

Drug: LY2928057

100 mg LY2928057 (Cohort 2)

EXPERIMENTAL

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.

Drug: LY2928057

300 mg LY2928057 (Cohort 3)

EXPERIMENTAL

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.

Drug: LY2928057

1000 mg LY2928057 (Cohort 4)

EXPERIMENTAL

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.

Drug: LY2928057

Interventions

Placebo DRUG

Single intravenous placebo dose.

Placebo

LY2928057 DRUG

Single intravenous dose.

Also known as: Ferroportin antibody

100 mg LY2928057 (Cohort 2); 1000 mg LY2928057 (Cohort 4); 30 mg LY2928057 (Cohort 1); 300 mg LY2928057 (Cohort 3)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Intend to use over-the-counter or prescription medication within 14 days before dosing, other than oestrogen/progesterone as hormone replacement therapy (HRT). Participants taking these medications are expected to be on chronic, stable doses. Certain medications (for example, vitamin supplements) may be permitted at the discretion of the investigator.
• Have donated more than 450 milliliter (mL) of blood within the last 3 months
• Have a regular alcohol intake greater than 21 units per week (male), or 14 units per week (female), or are unwilling to stop alcohol as required for the study (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of spirits)
• Are a smoker (smoking more than 10 cigarettes per day) or have used equivalent tobacco products. Participants will not be allowed to smoke while in the study unit.
• Have received live vaccine(s) within 1 month of screening, or intend to during the study

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, Singapore

Location

Related Publications (1)

• Sheetz M, Barrington P, Callies S, Berg PH, McColm J, Marbury T, Decker B, Dyas GL, Truhlar SME, Benschop R, Leung D, Berg J, Witcher DR. Targeting the hepcidin-ferroportin pathway in anaemia of chronic kidney disease. Br J Clin Pharmacol. 2019 May;85(5):935-948. doi: 10.1111/bcp.13877. Epub 2019 Mar 4.

  PMID: 30677788 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: April 7, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 30, 2018
• Results First Posted: July 30, 2018

Record last verified: 2017-10

Locations

SG (1)