PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).

NCT07025681 | Recruiting Phase 3

• 1 other identifier: 2024/CT/01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy

Keywords

Erythropoietin; cross over; Eprex; Double blinded

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  The PK parameter Cmax shall be calculated by noncompartmental analysis using Phoenix® WinNonlin. The maximum observed serum EPO concentration (Cmax) shall be directly obtained from the data.

  144.00±1* hours following drug administration after each dose.

• Reticulocyte count (%)

  As primary PD parameter, maximum effect change (Delta Emax) and the area under the baseline-adjusted effect curve (Delta AUEC) shall be calculated by the linear trapezoidal method for the RET count.

  312±1 hours post dose.

• Area under the plasma concentration versus time curve (AUC)

  The PK parameters shall be calculated by noncompartmental analysis using Phoenix® WinNonlin. The maximum observed serum EPO concentration (Cmax) and the time of Cmax (Tmax) shall be directly obtained from the data. The AUClast shall be calculated by the linear trapezoidal method up to Tmax and by the log trapezoidal method after Tmax. The area under the curve extrapolated to infinity (AUCinf) shall be obtained with the following formula: AUCinf=AUClast+Clast, where Clast is the last observed serum EPO concentration and lambda z is a calculated terminal elimination rate constant.

  144.00±1* hours following drug administration

Secondary Outcomes (3)

• t1/2

  144.00±1* hours following drug administration.

• Immunogenicity

  At 00.00 hours of period I and at 312±1 hours post dose of period II

• Hemoglobin

  From baseline and up to 312±1 hours following drug administration

Study Arms (2)

Erythropoietin 4000 IU Injection of Incepta Pharmaceuticals Ltd

EXPERIMENTAL

Erythropoietin 4000 IU Injection, subcutaneous injection manufactured by Incepta Pharmaceuticals Ltd will be administered.

Biological: Erythropoietin alfa

Eprex 4000 by Janssen-Cilag Ltd

ACTIVE COMPARATOR

Eprex 4000, subcutaneous injection manufactured by Janssen-Cilag Ltd will be administered.

Biological: Erythropoietin alfa

Interventions

Erythropoietin alfa BIOLOGICAL

Erythropoietin 4000 IU Injection, for subcutaneous injection.

Eprex 4000 by Janssen-Cilag Ltd; Erythropoietin 4000 IU Injection of Incepta Pharmaceuticals Ltd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• BMI of 18.0-30.0kg/m2.
• Voluntarily participants who agree to observe the precautions in writing after receiving a complete explanation of this trial.
• Willingness and ability to undertake all scheduled visits and assessments.
• Subject who have no evidence of underlying disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study.
• Subjects whose screening laboratory values are within normal limits or considered by the Investigator to be of no clinical significance.
• Non-smokers, ex-smokers and light smokers can be included in the study. "Light smokers are defined as someone smoking \< 10 cigarettes per day, ex-smokers as someone who completely stopped smoking for at least 03 months.
• No alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year.
• Subjects should not have consumed grape fruit juice or its products 72 hours before dosing and throughout the study periods.
• For Female Subjects:
• Subjects having negative urine pregnancy test.
• Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• Postmenopausal for more than 1 year.
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• Subjects with any previous exposure to erythropoiesis stimulating agents.
• History of clinically significant illness related to liver (including viral hepatitis), kidney, nervous system, immune system, respiratory system, endocrine system, cardiovascular system, blood system and tumor as well as mental illness (mood disorder, obsessive-compulsive disorder, etc.)
• Hypersensitivity or clinically significant hypersensitivity to the drug (e.g. aspirin, antibiotics, etc.)
• Those whose results meet more than one of the followings in the screening including re-test; Hemoglobin level below 12g/dL or over 17g/dL, Ferritin level below 21.8ng/mL, Transferrin level below 190mg/dL, Reticulocyte level \>2.5%, erythrocytes level \> 5.2x 106/mm3, platelets or serum potassium level over normal range.
• Positive on the HIV antibody, HBsAg, HCV (Hepatitis C Virus) antibody tests.
• Those whose vital signs measured in sitting position after resting over 3 minutes meet more than one of the following; Systolic BP below 90mmHg or over 160mmHg, Diastolic BP below 50mmHg or over 100mmHg, Pulse rate over 100.
• Those who received the following diagnosis within 6 months prior to the screening; Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all kinds), Chronic or uncontrollable inflammatory diseases (e.g., rheumatoid arthritis, systemic erythematosus)
• Those who participated other clinical trials and was administered other drugs within 3 months prior to the scheduled dose.
• Those who bled over 400mL or donated blood within 8 weeks prior to the scheduled first dose.
• Those who are considered inappropriate for the trial by the trial investigator based on the result of clinical laboratory test or due to other reasons.
• Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.

Sponsors & Collaborators

• Incepta Pharmaceuticals Ltd: lead
• Institute for Developing Science and Health Initiatives, Bangladesh: collaborator

Study Sites (1)

Universal Medical College and Hospital

Dhaka, Dhaka Division, 1215, Bangladesh

RECRUITING

Related Publications (6)

• Yan X, Lowe PJ, Fink M, Berghout A, Balser S, Krzyzanski W. Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575. J Clin Pharmacol. 2012 Nov;52(11):1624-44. doi: 10.1177/0091270011421911. Epub 2011 Dec 12.

  PMID: 22162538 BACKGROUND

• Yoon S, Rhee SJ, Heo SJ, Oh TY, Yoon SH, Cho JY, Lee S, Yu KS. Comparable pharmacokinetics and pharmacodynamics of two epoetin alfa formulations Eporon(R) and Eprex(R) following a single subcutaneous administration in healthy male volunteers. Drug Des Devel Ther. 2017 Oct 27;11:3127-3135. doi: 10.2147/DDDT.S142673. eCollection 2017.

  PMID: 29138535 BACKGROUND

• Elliott S, Pham E, Macdougall IC. Erythropoietins: a common mechanism of action. Exp Hematol. 2008 Dec;36(12):1573-84. doi: 10.1016/j.exphem.2008.08.003. Epub 2008 Oct 14.

  PMID: 18922615 BACKGROUND

• Rashidi A, Garimella PS, Al-Asaad A, Kharadjian T, Torres MN, Thakkar J. Anemia Management in the Cancer Patient With CKD and End-Stage Kidney Disease. Adv Chronic Kidney Dis. 2022 Mar;29(2):180-187.e1. doi: 10.1053/j.ackd.2022.03.005.

  PMID: 35817525 BACKGROUND

• Portoles J, Martin L, Broseta JJ, Cases A. Anemia in Chronic Kidney Disease: From Pathophysiology and Current Treatments, to Future Agents. Front Med (Lausanne). 2021 Mar 26;8:642296. doi: 10.3389/fmed.2021.642296. eCollection 2021.

  PMID: 33842503 BACKGROUND

• Jelkmann W. Physiology and pharmacology of erythropoietin. Transfus Med Hemother. 2013 Oct;40(5):302-9. doi: 10.1159/000356193. Epub 2013 Jul 19.

  PMID: 24273483 BACKGROUND

Study Officials

• Dr. Umme Kulsum

  Institute for developing Science and Health initiatives (ideSHi), Dhaka-1206, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faez Ahmed

CONTACT

+8801714086066; faez@inceptapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 17, 2025
• Study Start: April 24, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After completion of study
• Access Criteria: Journal

Locations

BA (1)