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Trial registered on ANZCTR
Registration number
ACTRN12613000374763
Ethics application status
Approved
Date submitted
26/03/2013
Date registered
8/04/2013
Date last updated
18/04/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Phase 1 Single Blind, Randomized, Single-Dose, Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Study of ZY7318 (pegylated recombinant human erythropoietin) in Healthy Volunteers
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Scientific title
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
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Secondary ID [1]
282192
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Nil
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Universal Trial Number (UTN)
U1111-1141-1074
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers study and investigational product would be targeted for secondary anemia due to renal cause.
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Condition category
Condition code
Renal and Urogenital
289049
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
Comparator arm would be placebo which would be sterile normal saline solution
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Control group
Placebo
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Outcomes
Primary outcome [1]
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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.
1. Number of subjects with adverse events;
2. Physical examinations (Vital Signs);
3. Electrocardiograms (ECG);
4. Laboratory tests (including hematology, biochemistry,
and urinalysis).
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Assessment method [1]
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Timepoint [1]
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12 lead ECG would be at Day 1 & Day 42.
laboratory tests would be analyzed at screening, admission day, Day 1, 2 3, 12, 21, 28 & Day 42.
Vital signs would be measured through the conduct of the study beginning from screening to Day 42.
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Secondary outcome [1]
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To determine the pharmacodynamic and pharmacokinetic profile of ZY7318 in healthy male volunteers based on the following parameters:
1. Pharmacodynamic Evaluation
a. Change in reticulocyte count, over time for 21
days across various treatment groups;
b. Change in Hemoglobin level;
c. Change in Hematocrit level.
2. Pharmacokinetic Evaluation:
a. Peak serum concentration (Cmax);
b. Time to reach peak serum concentration (Tmax);
c. Area under serum concentration vs. time curve till
the last time point (AUC 0-t);
d. Area under serum concentration vs. time curve
extrapolated to the infinity
e. The residual area in percentage
f. Serum elimination half-life (t 1/2);
g. Elimination rate constant
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Assessment method [1]
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Timepoint [1]
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Day 42 after drug administration
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed, as only subjects would be kept blinded
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization sheet would be generated by using a software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics / pharmacodynamics
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Statistical methods / analysis
Pharmacodynamic Analysis
Pharmacodynamic analysis will calculated using the following assessments:
Change in reticulocyte count, over time for 21 days across the cohorts and treatment groups;
Change in hemoglobin level over 42 days;
Change in hematocrit level over 42 days.
Comparisons between each treatment groups will be made using the difference in least-square means and p-values from the ANOVA model. Statistical significance will be defined as a two- sided p-value <0.05
Pharmacokinetic Analysis
Mean values by treatment received will be calculated for the following PK parameters for ZY7318:
Cmax--the maximum measured serum concentration;
tmax--the time to reach maximum serum concentration;
AUC0-last --the area under the serum concentration versus time curve from time zero to the time of the last measurable serum concentration, calculated by the linear or log/linear
trapezoidal method.
AUC0-inf--the area under the serum concentration versus time curve from time zero to infinity, calculated as:AUCinf = AUCt+(Ct/Kel), where Ct=the last measurable concentration.
z--the apparent elimination rate constant
t1/2--the terminal half-life
CV --coefficient of variation
Based on other safety studies & keeping in mind four different dosages in each cohort, we feel that 32 subjects sample size is adequate to permit assessment of the safety and pharmacokinetics of pegylated erythropoietin-based product.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/03/2013
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Actual
5/03/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Prolong Pharmaceuticals, LLC
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Address [1]
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300-B Corporate Court South Plainfield, NJ 07080-2415
USA
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Prolong Pharmaceuticals, LLC
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Address
300-B Corporate Court South Plainfield, NJ 07080-2415
USA
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Country
United States of America
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Secondary sponsor category [1]
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Commercial sector/Industry
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Name [1]
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Southern Star Research
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Address [1]
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Suite 501, 7-9 Merriwa Street, Gordon NSW 2072
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Paul Griffin
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Address
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Q-Pharm Pty Limited
P O Box 78
Royal Brisbane Hospital Qld 4029
Australia
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Country
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Australia
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Phone
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+61 0402 077 302
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Fax
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+61 7 3845 3636
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Glenn Kazo
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Address
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Prolong Pharmaceuticals, 300B Corporate Court, South Plainfield, NJ 07080, USA
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Country
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United States of America
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Phone
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+1-908-444-4651
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Abe Abuchowski
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Address
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Prolong Pharmaceuticals
300 Corporate Court
South Plainfield, NJ 07080, USA
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Country
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United States of America
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Phone
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+1-908-444-4650
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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