A First Human Study of a Ferroportin Antibody

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330953
• Other study ID #: 14151
• Secondary ID: I5M-FW-FABA
• Status: Completed
• Phase: Phase 1
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Placebo
Single intravenous placebo dose.
• LY2928057
Single intravenous dose.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinically Significant Adverse Effects	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.	Baseline through Day 85
Secondary	Pharmacokinetics, Area Under the Curve (AUC)	Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-8).	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
Secondary	Pharmacokinetics, Maximum Concentration (Cmax)		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
Secondary	Pharmacokinetics, Time to Maximum Concentration (Tmax)		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
Secondary	Pharmacokinetics, Systemic Clearance (CL)	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).	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
Secondary	Pharmacokinetics, Volume of Distribution (V)	V=LY2928057 steady-state volume of distribution (Vss)	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
Secondary	Pharmacokinetics, Terminal Half-Life (t1/2)		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
Secondary	Change From Baseline in Serum Iron	Maximum change from baseline to any point over 22 days post-infusion.	Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22
Secondary	Number of Participants Forming Antibody to LY2928057		Baseline through Day 85