Actively Recruiting
PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).
Led by Incepta Pharmaceuticals Ltd · Updated on 2025-06-17
56
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
Sponsors
I
Incepta Pharmaceuticals Ltd
Lead Sponsor
I
Institute for Developing Science and Health Initiatives, Bangladesh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Erythropoietin, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. Erythropoietin binds to the surface receptor of erythroid precursor cells and activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation. Recombinant human erythropoietin is a substitute for the deficiency observed in CKD, therapy of anemia often involves many other issues such as Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin \> 10 to \< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients are also needed to be considered in order to effectively correct anemia, reduce costs and minimize side effects.
CONDITIONS
Official Title
PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body mass index (BMI) between 18.0 and 30.0 kg/m2
- Voluntarily agree to follow study precautions after full explanation
- Willingness and ability to attend all scheduled visits and assessments
- No signs of underlying disease based on screening, medical history, and physical exam within 28 days before the study
- Screening laboratory test results within normal limits or clinically acceptable
- Non-smokers, ex-smokers (stopped smoking for at least 3 months), or light smokers (less than 10 cigarettes per day)
- No alcohol or drug abuse within the past year
- No consumption of grapefruit juice or its products 72 hours before dosing and during the study
- For female participants: negative pregnancy test, use of acceptable birth control during the study or postmenopausal for more than 1 year, or surgically sterile
You will not qualify if you...
- Previous exposure to erythropoiesis stimulating agents
- History of significant illness affecting liver, kidney, nervous, immune, respiratory, endocrine, cardiovascular, blood systems, tumors, or mental health disorders
- Known allergy or significant hypersensitivity to drugs like aspirin or antibiotics
- Abnormal screening results including hemoglobin below 12 g/dL or above 17 g/dL, ferritin below 21.8 ng/mL, transferrin below 190 mg/dL, reticulocytes above 2.5%, erythrocytes above 5.2 million/mm3, or abnormal platelets or potassium levels
- Positive tests for HIV, hepatitis B surface antigen, or hepatitis C antibody
- Abnormal vital signs including blood pressure or pulse rate outside specified ranges
- Diagnosed within 6 months prior to screening with hemoglobinopathies or chronic inflammatory diseases
- Participation in other clinical trials with drug administration within 3 months prior to dosing
- Blood loss over 400 mL or blood donation within 8 weeks before first dose
- Deemed unsuitable for the trial by the investigator
- Employees, family members of study staff, prisoners, or legally institutionalized persons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universal Medical College and Hospital
Dhaka, Dhaka Division, Bangladesh, 1215
Actively Recruiting
Research Team
F
Faez Ahmed
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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