A Phase 1 Single Blind, Randomized, Single-Dose, Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Study of ZY7318 (pegylated recombinant human erythropoietin) in Healthy Volunteers
A Phase 1 single-blind, single-treatment, pharmacodynamic and pharmacokinetic study of ZY7318 (pegylated recombinant human erythropoietin) in thirty two(32) healthy adult male volunteers
Prolong Pharmaceuticals, LLC
32 participants
Mar 5, 2013
Interventional
Conditions
Summary
This is first-in-Man study involving 32 healthy adult male subjects. Overall purpose of the study is to assess safety of pegylated human erythropoietin & tolerability in terms of plasma concentrations in normal male healthy volunteers.
Eligibility
Inclusion Criteria10
- Able to provide written Informed Consent;
- Ability to communicate effectively with study personnel;
- Willingness to adhere to the protocol requirements;
- Male healthy volunteers;
- Age greater than or equal to 18 years and less than or equal to 45 years;
- Body Mass Index=20-=30 kg/m2.
- In good general health with no clinically significant illness seen on physical examination or ongoing medical history,as determined by the Investigator;
- Documented 12 lead ECG with no clinically significant abnormalities, as determined by the Investigator;
- No clinically significant abnormalities in screening or Day-1 laboratory tests, as determined by the Investigator;
- Hemoglobin between 12-17g/dL.
Exclusion Criteria24
- Any prior treatment with Erythropoiesis-Stimulating Agents (ESAs);
- History of hypersensitivity to erythropoietin or any related drug;
- Active liver disease and/or liver transaminases greater than 1.5X upper limit of normal;
- History of anemia;
- History or presence of blood dyscrasias (e.g. thrombocytopenia, neutropenia);
- History or presence of thyroid disorders;
- History of presence of pulmonary disorders (e.g. dyspnea, pneumonia);
- History or presence of autoimmune disorders (e.g. thyroiditis, rheumatoid arthritis);
- History or presence of arrhythmia or any other cardiovascular disease
- Subjects taking drugs that have a narrow therapeutic index(e.g.anti-epileptics,etc.)and drugs that can depress the immune system(e.g. anti-cancer drugs, etc.);
- Blood pressure less than 90/60 (Systolic/diastolic)mm Hg or more than 140/90 mm Hg;
- Febrile;
- Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator;
- Donated blood within 60 days of screening or otherwise experienced blood loss of>250mL within the same period;
- Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug;
- Received or intending to receive a vaccination in the two weeks prior to dosing, or any time during study participation;
- Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment;
- History of drug and/or alcohol dependence within past 12 months,and/or positive results on drug of abuse or alcohol tests;
- Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency;
- Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination;
- Has taken any regular,prescribed,or over-the-counter medication with the exception of acetaminophen (maximum2g/day) or multi-vitamins in the two weeks prior to dosing(other medication may only be taken with the specific approval of the Investigator in consultation with the Medical Monitor);
- Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri;
- Unable to comply with study attendance, protocol procedures or other study requirements;
- Any condition that, in the opinion of the investigator, might interfere with study objectives.
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Interventions
A Phase 1 single-blind,single-treatment, pharmacodynamic and pharmacokinetic study of ZY7318 (pegylated recombinant human erythropoietin) in thirty two(32) healthy adult male volunteers enrolled in four cohorts, each consisting of eight (8) subjects. Each cohort of 8 subjects will consist of 6 subjects assigned to active study drug and 2 subjects assigned to placebo. For each cohort, six(6) subjects will receive active study drug and two (2)subjects will receive placebo as per the randomization sequence. Randomization ratio would be 3:1. Being a single blind study,only subjects would be kept blinded. The Principal Investigator or designee will review adverse events and vital signs of the first 2 dosed subjects (1 active treatment,1 placebo) at 24 hours before approving the dosing of the subsequent subjects in each cohort. Each cohort must be completed and reviewed by the Principal Investigator and the Medical Monitor,or their designees, after three days once last subject dosed in that cohort before moving to the next higher dose cohort. Cohort wise Investigational product dosage & administration would be as follows:-- 1st cohort - ZY7318 0.15 mcg/kg 2nd cohort - ZY7318 0.3 mcg/kg 3rd cohort - ZY7318 0.6 mcg/kg 4th cohort - ZY7318 0.9 mcg/kg Placebo (Sterile Normal Saline Solution) Route of administration would be subcutaneous route.
Locations(1)
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ACTRN12613000374763