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Completed

NCT Number: NCT01330953

A First Human Study of a Ferroportin Antibody

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Single intravenous placebo dose.

LY2928057

Drug

Single intravenous dose.

Other names: Ferroportin antibody

Primary outcomes

  1. 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

  1. Pharmacokinetics, Area Under the Curve (AUC)

    Time frame: 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

    Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞).

  2. Pharmacokinetics, Maximum Concentration (Cmax)

    Time frame: 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

  3. Pharmacokinetics, Time to Maximum Concentration (Tmax)

    Time frame: 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

  4. Pharmacokinetics, Systemic Clearance (CL)

    Time frame: 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

    CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3).

  5. Pharmacokinetics, Volume of Distribution (V)

    Time frame: 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

    V=LY2928057 steady-state volume of distribution (Vss)

  6. Pharmacokinetics, Terminal Half-Life (t1/2)

    Time frame: 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

  7. Change From Baseline in Serum Iron

    Time frame: Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22

    Maximum change from baseline to any point over 22 days post-infusion.

  8. Number of Participants Forming Antibody to LY2928057

    Time frame: Baseline through Day 85

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2011
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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