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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Placebo
Drug: LY2928057
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2928057 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of participants with clinically significant adverse effects [ Time Frame: Baseline to study completion (estimate of 6 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: March 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Single dose administered intravenously
Drug: Placebo
Administered intravenously
Experimental: LY2928057 30 mg
Single dose LY2928057 administered intravenously at 30 mg
Drug: LY2928057
Administered intravenously
Other Name: Ferroportin Antibody
Experimental: LY2928057 100 mg
Single dose LY2928057 administered intravenously at 100 mg
Drug: LY2928057
Administered intravenously
Other Name: Ferroportin Antibody
Experimental: LY2928057 300 mg
Single dose LY2928057 administered intravenously at 300 mg
Drug: LY2928057
Administered intravenously
Other Name: Ferroportin Antibody
Experimental: LY2928057 1000 mg
Single dose LY2928057 administered intravenously at 1000 mg
Drug: LY2928057
Administered intravenously
Other Name: Ferroportin Antibody

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330953

Locations
Singapore
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01330953     History of Changes
Other Study ID Numbers: 14151, I5M-FW-FABA
Study First Received: March 15, 2011
Last Updated: September 26, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Eli Lilly and Company:
Anemia

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014