ClinicalTrials.gov
ClinicalTrials.gov Menu

A First Human Study of a Ferroportin Antibody

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01330953
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Placebo Drug: LY2928057 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Single intravenous placebo dose.
Drug: Placebo
Single intravenous placebo dose.

Experimental: 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.
Drug: LY2928057
Single intravenous dose.
Other Name: Ferroportin antibody

Experimental: 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.
Drug: LY2928057
Single intravenous dose.
Other Name: Ferroportin antibody

Experimental: 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.
Drug: LY2928057
Single intravenous dose.
Other Name: Ferroportin antibody

Experimental: 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.
Drug: LY2928057
Single intravenous dose.
Other Name: Ferroportin antibody




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01330953     History of Changes
Other Study ID Numbers: 14151
I5M-FW-FABA ( Other Identifier: Eli Lilly and Company )
First Posted: April 7, 2011    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: October 2017

Keywords provided by Eli Lilly and Company:
Anemia

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