A Phase 1 Single Blind, Randomized, Single-Dose, Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Study of ZY7318 (pegylated recombinant human erythropoietin) in Healthy Volunteers
- Conditions
- Healthy volunteers study and investigational product would be targeted for secondary anemia due to renal cause.Renal and Urogenital - Kidney disease
- Registration Number
- ACTRN12613000374763
- Lead Sponsor
- Prolong Pharmaceuticals, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 32
1.Able to provide written Informed Consent;
2.Ability to communicate effectively with study personnel;
3.Willingness to adhere to the protocol requirements;
4.Male healthy volunteers;
5.Age greater than or equal to 18 years and less than or equal to 45 years;
6.Body Mass Index=20-=30 kg/m2.
7.In good general health with no clinically significant illness seen on physical examination or ongoing medical history,as determined by the Investigator;
8.Documented 12 lead ECG with no clinically significant abnormalities, as determined by the Investigator;
9.No clinically significant abnormalities in screening or Day-1 laboratory tests, as determined by the Investigator;
10.Hemoglobin between 12-17g/dL.
1.Any prior treatment with Erythropoiesis-Stimulating Agents (ESAs);
2.History of hypersensitivity to erythropoietin or any related drug;
3.Active liver disease and/or liver transaminases greater than 1.5X upper limit of normal;
4.History of anemia;
5.History or presence of blood dyscrasias (e.g. thrombocytopenia, neutropenia);
6.History or presence of thyroid disorders;
7.History of presence of pulmonary disorders (e.g. dyspnea, pneumonia);
8.History or presence of autoimmune disorders (e.g. thyroiditis, rheumatoid arthritis);
9.History or presence of arrhythmia or any other cardiovascular disease
10.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.);
11.Blood pressure less than 90/60 (Systolic/diastolic)mm Hg or more than 140/90 mm Hg;
12.Febrile;
13.Physical examination or 12-lead ECG result(s) considered to be clinically significant by the Investigator;
14.Donated blood within 60 days of screening or otherwise experienced blood loss of>250mL within the same period;
15.Intending to begin new concomitant drug therapy or over-the-counter medication anytime from screening to the time of administration of study drug;
16.Received or intending to receive a vaccination in the two weeks prior to dosing, or any time during study participation;
17.Received treatment with a drug that has not received regulatory approval for an indication during the 60 days preceding study enrollment;
18.History of drug and/or alcohol dependence within past 12 months,and/or positive results on drug of abuse or alcohol tests;
19.Screening laboratory result indicating HIV-positivity, or previously diagnosed with AIDS, AIDS related complex, or other immunodeficiency;
20.Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination;
21.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);
22.Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma and carcinoma in situ uteri;
23.Unable to comply with study attendance, protocol procedures or other study requirements;
24.Any condition that, in the opinion of the investigator, might interfere with study objectives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of increasing doses of ZY7318 in healthy male volunteers e.g. abnormal lab parameter, if any, vomiting, headache, etc.<br><br>1.Number of subjects with adverse events;<br>2.Physical examinations (Vital Signs);<br>3.Electrocardiograms (ECG);<br>4.Laboratory tests (including hematology, biochemistry, <br> and urinalysis).[12 lead ECG would be at Day 1 & Day 42.<br>laboratory tests would be analyzed at screening, admission day, Day 1, 2 3, 12, 21, 28 & Day 42.<br>Vital signs would be measured through the conduct of the study beginning from screening to Day 42.]
- Secondary Outcome Measures
Name Time Method To determine the pharmacodynamic and pharmacokinetic profile of ZY7318 in healthy male volunteers based on the following parameters:<br>1.Pharmacodynamic Evaluation<br> a. Change in reticulocyte count, over time for 21 <br> days across various treatment groups;<br> b. Change in Hemoglobin level;<br> c. Change in Hematocrit level.<br>2.Pharmacokinetic Evaluation:<br> a.Peak serum concentration (Cmax);<br> b.Time to reach peak serum concentration (Tmax);<br> c.Area under serum concentration vs. time curve till <br> the last time point (AUC 0-t);<br> d.Area under serum concentration vs. time curve <br> extrapolated to the infinity<br> e.The residual area in percentage <br> f.Serum elimination half-life (t 1/2);<br> g.Elimination rate constant [Day 42 after drug administration]