CTRI/2023/01/049031已完成1 期
A Single Dose, Double-Blind, Two-Period, Two Sequence, Crossover Comparative Pharmacokinetic Study of DRL_DA, and EU approved Reference Medicinal Product (Aranesp®), Administered by the Intravenous Route to Male Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 of 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 (Clinical Trials Facilitation and Coordination Group) guidelines 2014 include the following:
- •For Subject:
- •5.1 Permanently sterile by bilateral orchidectomy
- •5.2 Sexual abstinence
- •For female partner of male Subject
- •5.3 Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral, intravaginal, and transdermal;
- •5.4 Progestogen-only hormonal contraception associated with inhibition of ovulation - oral, injectable, implantable;
- •5.5 Intrauterine device;
- •5.6 Intrauterine hormone-releasing system;
- •5.7 Bilateral tubal occlusion;
- •5.8 Vasectomized partner;
- •5.9 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 period if and as applicable.
排除标准
- •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 higher than ULN - 0.5 gm/dl ?; reticulocyte percent >3% serum ferritin <100 mcg/L or transferrin saturation NOT within the normal laboratory reference range for the study site or transferrin or serum vitamin B12 or folate below the lower limit of the reference range at Screening.
- •Note: ULN – 0.5 gm/dl ?: Upper Limit of Normal reference range of the study site for haemoglobin subtracted with 0.5 gm/dl
- •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.
- •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. This criterion also includes any disorder or condition that, in the Investigator’s opinion, may interfere with the safety of the subject, the study evaluations o
研究者
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