None listed
Conditions
Interventions
Intervention1: Dr. Reddys Darbepoetin alfa (DRL_DA): Each subject will receive two SC doses of 60 mcg of Investigational Medicinal Product separated by a minimum of 42 days of washout.
Control Interv
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male volunteers, 18 to 50 years of age (both age inclusive) at the time of signing informed consent 2. Body mass index between 18.5 – 30.0 kg/m2 (both inclusive) and body weight between 55.0 – 95.0 kg (both inclusive) 3. In general, good health as determined by a qualified physician based on a comprehensive medical history, physical examination including vital signs, laboratory hematology, clinical chemistry, urinalysis, and 12-lead electrocardiogram (ECG) before randomization. 4. Screening parameters (vital signs, physical examination, clinical laboratory tests, 12-lead ECG, thyroid function and coagulation parameters) within the normal range or outside the normal range but assessed as clinically non-significant by the Investigator (unless the value constitutes an explicit exclusion criterion). 5. Subjects or their female partner (if they are WOCBP) must be willing to use at least one highly effective method of contraception as described below from the time of first Investigational Medicinal Product (IMP) administration until 3 months after last dosing (Second period dosing). Highly effective birth control measures per CTFG guidelines 2014 include the following: For Subject: · Permanently sterile by bilateral orchidectomy · Sexual abstinence For female partner of male Subject · Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, and transdermal; · Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, implantable; · Intrauterine device; · Intrauterine hormone-releasing system; · Bilateral tubal occlusion; · Vasectomized partner; · Sexual abstinence 6. Capable, and amenable to providing written informed consent to the study requirements 7. Willing to stay on study restrictions for 16 weeks and abide by the study processes during the follow up if and as applicable.
Exclusion criteria
Exclusion criteria: 1. Positive test result for syphilis, hepatitis B, hepatitis C, or HIV-1 or -2. 2. Any prior exposure to darbepoetin or to any other erythropoiesis stimulating agent including investigational products [example: Epogen® (epoetin alfa) and its biosimilar/s]. 3. Allergy or hypersensitivity to any recombinant human or humanized antibodies, other therapeutic proteins, or any excipients in the study formulations as well as latex allergy. 4. Hemoglobin concentration NOT between 12 – 14 gm/dl (both values subjects are eligible);reticulocyte percent >3%; serum ferritin 5. Known history or presence of hemoglobinopathies including but not limited to sickle cell disease or trait and thalassemias. If suspecting any, to be ruled out by appropriate tests. 6. History and/or current presence of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma including childhood asthma, urticaria, angioedema, eczematous dermatitis), hypersensitivity or allergic reactions or any history or presence of vasculitis or psoriasis as well as any skin disease or presence of tattoos interfering with the evaluation of all possible injection sites. 7. Blood donation, participation in any study requiring repeated blood sampling or hemorrhage requiring treatment or any transfusion in the past 3 months. 8. Screening or baseline blood pressure higher than 140 mm Hg (systolic) or higher than 90 mm Hg (diastolic) or volunteers currently on anti-hypertensive drugs. Note: Up to two repeats in different days are allowed (repeats on the same visit can be done if white coat hypertension is suspected) and, in this case, the mean of the measurements will be used to decide on eligibility. Blood pressure is to be measured in the sitting position after 5 minutes rest on the same position. 9. History of relevant (in the Opinion of the Investigator) orthostatic hypotension, fainting spells, or blackouts as well as history of difficulties with blood sampling which potentially may interfere with the study objectives, as per the opinion of the Investigator. 10. QTc (Fridericia correction) longer than 450 milliseconds or other ECG abnormalities such as atrial fibrillation, atrial flutter, Wolf-Parkinson-White syndrome, or presence of a cardiac pacemaker or any other ECG abnormality considered clinically relevant by the Investigator. 11. History or presence of any clinically relevant nervous system disease including, but not restricted to any stroke/TIA or of seizures other than febrile seizures before the age of 5 years. 12. History of and/or current gastrointestinal, neurological, renal, endocrine, pulmonary, hepatic, cardiovascular (including history of or presence of angina, exertional dyspnea, orthopnea, congestive heart failure or myocardial infarction and thrombotic or embolic episode requiring treatment), hematological [including pancytopenia, aplastic anemia, or blood dyscrasia and coagulopathies or an International Normalized Ratio (INR) higher than 1.5] or metabolic (including known diabetes mellitus) disease. 13. Participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters (calculated by standard non-compartmental methods on actual sampling times): Cmax, AUC (0-t), AUC(0-8)Timepoint: Samples for PK analysis will be obtained in each period at 1 hour, 30 min&15 min prior to the administration of IMP with an window of 10 minutes, & at post dose, 2h, 4h, 8h, 12h, 16h, 24h, 32h, 40h, 48h (day 3), 72h (day 4), 96h (day 5), 120h (Day 6), 168h (day 8), 216h (day 10), 264h (day 12) & 360h (day 16). | — |
Secondary
| Measure | Time frame |
|---|---|
| Reticulocyte count & % is a pharmacodynamic endpoint and secondary endpoint. immunogenicity assessment.Timepoint: PD: 11 blood samples will be obtained at pre-dose & 24h, 36h, 48h (day 3), 72h (day 4), 96h (day 5), 120h (Day 6), 168h (day 8), 216h (day 10), 264h (day 12) and 360h (day 16) after start of IMP administration in each period. Immunogenicity: Total 7 samples at pre-dose of both Periods, on Day16 and 29 of each period and at the EOS visit. | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah
Dr. Reddy’s Laboratories Ltd
Outcome results
None listed