Comparison of two erythropoietin injections from Incepta and Eprex.
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
This test checks whether a single 4000 IU injection of Incepta’s erythropoietin acts like Eprex in healthy adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Incepta Pharmaceuticals Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dhaka, Dhaka Division) |
| Trial ID | NCT07025681 on ClinicalTrials.gov |
What this trial studies
In a randomized, double-blinded, balanced two-treatment, two-period, two-sequence single-dose crossover, 56 healthy adult volunteers will each receive a single 4000 IU subcutaneous dose of either Incepta’s erythropoietin or Eprex with a 28-day washout between doses. Blood samples will be collected over prespecified timepoints to compare pharmacokinetic and pharmacodynamic profiles, including measures related to red blood cell production. Immunogenicity will be evaluated by testing for anti-drug antibodies, and safety will be monitored throughout the study period. The crossover design in fasting healthy volunteers reduces variability and allows direct head-to-head comparison of the two formulations.
Who should consider this trial
Good fit: Healthy adults aged 18 or older with BMI 18.0–30.0 kg/m2, no significant underlying disease, and willingness to complete all visits and procedures are the ideal candidates.
Not a fit: People with anemia, chronic kidney disease, or those who require ongoing therapeutic erythropoietin are unlikely to receive direct clinical benefit from a single-dose healthy-volunteer trial.
Why it matters
Potential benefit: If the products are shown to be similar, this could provide an additional erythropoietin option that may improve availability and reduce cost for patients who need treatment.
How similar studies have performed: Previous crossover PK/PD studies of recombinant erythropoietin biosimilars have frequently shown comparable pharmacokinetic, pharmacodynamic, and safety profiles to reference products.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • 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:
1. Subjects having negative urine pregnancy test.
2. 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.
3. Postmenopausal for more than 1 year.
4. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Exclusion Criteria:
* • 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.
Where this trial is running
Dhaka, Dhaka Division
- Universal Medical College and Hospital — Dhaka, Dhaka Division, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Dr. Umme Kulsum — Institute for developing Science and Health initiatives (ideSHi), Dhaka-1206, Bangladesh
- Study coordinator: Faez Ahmed
- Email: faez@inceptapharma.com
- Phone: +8801714086066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.