A First Human Study of a Ferroportin Antibody

NCT ID: NCT01330953

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Single intravenous placebo dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single intravenous placebo dose.

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.

Group Type: EXPERIMENTAL

LY2928057

Intervention Type: DRUG

Single intravenous dose.

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.

Group Type: EXPERIMENTAL

LY2928057

Intervention Type: DRUG

Single intravenous dose.

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.

Group Type: EXPERIMENTAL

LY2928057

Intervention Type: DRUG

Single intravenous dose.

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.

Group Type: EXPERIMENTAL

LY2928057

Intervention Type: DRUG

Single intravenous dose.

Interventions

Placebo

Single intravenous placebo dose.

Intervention Type: DRUG

LY2928057

Single intravenous dose.

Intervention Type: DRUG

Other Intervention Names

Ferroportin antibody

Eligibility Criteria

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
• 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
• Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before receiving study drug in this study
• Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis)
• Have any active mental health illness
• Study doctor does not feel the participant should be in the study for any reason

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 30677788 (View on PubMed)

Other Identifiers

I5M-FW-FABA

Identifier Type: OTHER

Identifier Source: secondary_id

14151

Identifier Type: -

Identifier Source: org_study_id