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A First Human Study of a Ferroportin Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01330953
First received: March 15, 2011
Last updated: September 26, 2011
Last verified: September 2011

March 15, 2011
September 26, 2011
March 2011
September 2011   (final data collection date for primary outcome measure)
Number of participants with clinically significant adverse effects [ Time Frame: Baseline to study completion (estimate of 6 months) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01330953 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, Maximum concentration (Cmax) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time to maximum concentration (tmax) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, systemic clearance (CL) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, volume of distribution (V) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, terminal half-life (t1/2) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Change from baseline in serum iron [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15 and 22 ] [ Designated as safety issue: No ]
  • Number of subjects forming antibody to LY2928057 [ Time Frame: Baseline, day 8, 22, 43, and 85 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, area under the curve (AUC) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, Maximum concentration (Cmax) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, time to maximum concentration (tmax) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, systemic clearance (CL) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, volume of distribution (V) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Pharmacokinetics, terminal half-life (t1/2) [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85 ] [ Designated as safety issue: No ]
  • Change from baseline in serum iron [ Time Frame: Baseline, end of infusion, 4, 12 and 24 hours post infusion, on day 3, 5 and 15 ] [ Designated as safety issue: No ]
  • Number of subjects forming antibody to LY2928057 [ Time Frame: Baseline, day 8, 22, 43, and 85 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A First Human Study of a Ferroportin Antibody
A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Healthy Subjects

The purposes of this study are (1) To determine the safety of LY2928057 in healthy people, and any side effects that might be associated with it; (2) To understand how the body of healthy people handles LY2928057; (3) To determine the effect of LY2928057 on blood iron level in people's body; and (4) To evaluate how people's immune system reacts to LY2928057.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Placebo
    Administered intravenously
  • Drug: LY2928057
    Administered intravenously
    Other Name: Ferroportin Antibody
  • Placebo Comparator: Placebo
    Single dose administered intravenously
    Intervention: Drug: Placebo
  • Experimental: LY2928057 30 mg
    Single dose LY2928057 administered intravenously at 30 mg
    Intervention: Drug: LY2928057
  • Experimental: LY2928057 100 mg
    Single dose LY2928057 administered intravenously at 100 mg
    Intervention: Drug: LY2928057
  • Experimental: LY2928057 300 mg
    Single dose LY2928057 administered intravenously at 300 mg
    Intervention: Drug: LY2928057
  • Experimental: LY2928057 1000 mg
    Single dose LY2928057 administered intravenously at 1000 mg
    Intervention: Drug: LY2928057
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must either be a healthy male (and willing to use reliable method of birth control during the study and for 3 months following the last dose of study drug), or a healthy female who cannot become pregnant
  • Must have a body mass index (BMI) between 18.5 and 32.0 kg/m², inclusive and a minimum body weight of 55 kg
  • Blood and urine laboratory test results must be acceptable for the study
  • The veins must be suitable for easy blood collection and study drug administration
  • Must be reliable and willing to be available for the duration of the study and are willing to follow study procedures
  • Must have given written informed consent
  • Blood pressure and pulse rate must be acceptable for the study

Exclusion Criteria:

  • Blood test shows that subject has anemia due to lack of iron
  • Currently taking part in another clinical study or completed one less than 30 days ago
  • Allergic to biologic agents
  • Have previously taken part in this study
  • Have abnormal electrocardiogram (ECG) findings that suggests an increase in the risks associated with participating in the study
  • 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 drug or alcohol abuse
  • Are infected with human immunodeficiency virus (HIV)
  • Have hepatitis B
  • Are pregnant or breast feeding
  • Intend to use over-the-counter or prescription medication within 14 days prior to dosing, other than oestrogen/progesterone as hormone replacement therapy (HRT). Subjects taking these medications should 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 mL of blood within the last 3 months
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or you are unwilling to stop alcohol as required for the study (1 unit = 360 mL of beer, or 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. Subjects 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) prior to receiving study drug in this study
  • Have a history of atopy, or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
  • Have any active mental health illness
  • The study doctor thinks the subject should not participate for any reason
Both
21 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01330953
14151, I5M-FW-FABA
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP