A Single Dose, Double-Blind, Two-Period Crossover, Balanced Sequences, Comparative Pharmacokinetic Study with Separate Comparisons of Three Pairs of Products of DRL-Darbepoetin (DRL_DA), US licensed Reference Product (Aranesp®), and EU approved Reference Medicinal Product (Aranesp®), Administered by the Subcutaneous Route to Male Healthy Volunteers - DRL_DA

Dr. Reddys Laboratories Ltd.0 sites0 target enrollmentTBD

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Dr. Reddys Laboratories Ltd.
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Dr. Reddys Laboratories Ltd.

Eligibility 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;

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 \<100 mcg/L or transferrin saturation or total iron binding capacity 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.
•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.

Outcomes

Primary Outcomes

Not specified

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