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

Launched by INCEPTA PHARMACEUTICALS LTD · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called erythropoietin, which helps the body make more red blood cells. Red blood cells carry oxygen throughout the body, and erythropoietin is naturally made by the kidneys to support this process. The trial is comparing a new version made by Incepta Pharmaceuticals with an existing one called Eprex to see how safe it is, how the body responds to it, and how the medicine works in healthy adults.

The study is looking for healthy volunteers aged 18 and older who don’t have any serious health problems and meet certain health criteria, like having a normal body weight and blood tests within a healthy range. Participants should not have used similar medicines before or have any recent infections or major illnesses. During the trial, volunteers will visit the study site for tests and monitoring to check how their bodies react to the medicine. It’s important that participants agree to follow all study instructions and attend all scheduled visits. This trial helps researchers understand if the new erythropoietin works as well and is as safe as the current treatment, which could benefit people with conditions like anemia in the future.

Gender

ALL

Eligibility 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.