AzTrials
AzTrials

HealthyPhase 3NCT07025681

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

A Phase 3 study testing Erythropoietin alfa in people with Healthy, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Erythropoietin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteBangladesh
Study dates
24 Apr 2025to 23 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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.
Show all 14Show fewer
  • 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).

Who cannot join

  • • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site

  • Universal Medical College and Hospital

    Dhaka, 1215

Other trials in Bangladesh

About this study

Official title: Randomized, Double-blinded, Two-treatment, Two-periods, Single-dose, Crossover, PK, PD, Safety, and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex of Janssen-Cilag Ltd in Healthy Adult Subjects

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.

Read the detailed description

In this study, 56 healthy adult volunteers will participate in a randomized, double-blinded, balanced, two-treatment, two-period, two-sequence, single-dose crossover trial. Each subject will receive a single subcutaneous injection of either Erythropoietin 4000 IU manufactured by Incepta Pharmaceuticals Ltd (test product) or Eprex 4000 IU manufactured by Janssen-Cilag Ltd (reference product) under fasting conditions, with a 28-day washout period between doses. The primary aim of the study is to compare the pharmacokinetic and pharmacodynamic profiles of the two products. Additionally, the study will assess immunogenicity by measuring serum anti-drug antibodies (ADA) and evaluate the safety of both formulations throughout the study duration.

Conditions
Healthy
Being tested
Erythropoietin alfa
Keywords
Erythropoietin, cross over, Eprex, Double blinded

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erythropoietin alfaBiological

    Erythropoietin 4000 IU Injection, for subcutaneous injection.

Study groups in NCT07025681
Study groupRoleWhat they receive
Erythropoietin 4000 IU Injection of Incepta Pharmaceuticals LtdExperimentalErythropoietin 4000 IU Injection, subcutaneous injection manufactured by Incepta Pharmaceuticals Ltd will be administered.
Receives: Biological: Erythropoietin alfa
Eprex 4000 by Janssen-Cilag LtdActive comparatorEprex 4000, subcutaneous injection manufactured by Janssen-Cilag Ltd will be administered.
Receives: Biological: Erythropoietin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 312±1 hours post dose.

  3. 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.

    Measured: 144.00±1* hours following drug administration

Secondary outcomes (3)

  1. t1/2

    The terminal half-life (t1/2) shall be calculated by dividing natural-log2 by lambda z.

    Measured: 144.00±1* hours following drug administration.

  2. Immunogenicity

    By measuring Anti-drug Antibody (ADA) formation.

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

  3. Hemoglobin

    Mean absolute change in Hb levels between the baseline period (pre dose) and the evaluation period.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start24 Apr 2025
  3. Primary completion23 Sep 2025
  4. Study completion23 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025681
Sponsor's protocol ID
2024/CT/01
Status last verified
Nov 2026
First submitted
24 May 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: By publication in the journal

Publications

  • 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.

    PubMed 22162538

  • 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.

    PubMed 29138535

  • 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.

    PubMed 18922615

  • 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.

    PubMed 35817525

  • 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.

    PubMed 33842503

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

    PubMed 24273483

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erythropoietin alfa in people with Healthy, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Plasma Concentration (Cmax) (time frame: 144.00±1* hours following drug administration after each dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07025681, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in