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NCT06919861

PHASE1

Pharmacokinetics, Pharmacodynamics, and Safety of NANOKINE Compared With Eprex 4000 U in Healthy Volunteers

Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company

View on ClinicalTrials.gov

Summary

This clinical trial aims to compare the pharmacokinetic (PK), pharmacodynamic (PD) parameters, and safety between Nanokine of Nanogen Pharmaceutical Joint Stock Company and Eprex® of Janssen Cilag Ltd on healthy male volunteers. The biosimilarity of erythropoietin (EPO) between Nanokine (test) and Eprex® (comparator) was evaluated in a randomized, two-treatment, two-period, crossover, single-dose study. Subjects received a 4,000 IU subcutaneous dose of either formulation, followed by the alternate after a 28-day washout. Key pharmacokinetic (PK) parameters, Cmax and AUCinf, were assessed, with geometric mean ratios/GMR (90% CI) falling within the regulatory range (0.80-1.25). Pharmacodynamic (PD) marker (reticulocyte count) need to show comparable effects. Safety evaluation (adverse events and serious adverse events, other safety assessments such as vital signs, testing, and examination) supports their interchangeability in clinical use.

Official title: A Randomized, Two-treatment, Two-period, Crossover, Single-dose, Subcutaneous Injection Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Manufactured by Nanogen Pharmaceutical Biotechnology Joint Stock Company With Eprex 4000 U Manufactured by Cilag AG in Healthy Volunteers

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07

Completion Date

2027-06

Last Updated

2026-07-07

Healthy Volunteers

Yes

Conditions

Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

Interventions

BIOLOGICAL

Erythropoietin alfa

Experimental drug: Nanokine 4000 IU, prefilled syringe, subcutaneous injection Manufactured: Nanogen Biopharmaceutical JSC. Arm 1 (22 volunteers): Nanokineinjection 4000 IU will be administered subcutaneously on Day 1, and after a 28-day washout period, Eprex® injection 4000 IU will be administered subcutaneously on Day 29.

BIOLOGICAL

Erythropoietin alfa

Comparator drug: Eprex® 4000 IU, prefilled syringe, subcutaneous injection Manufactured: Janssen-Cilag Ltd Arm 2 (22 volunteers): Eprex® injection 4000 IU will be administered subcutaneously on Day 1, and after a 28-day washout period, Eprex injection 4000 IU will be administered subcutaneously on Day 29. Total: 44 participants will be recruited in the trial.

Inclusion Criteria: 1. Male, aged 18 to 45 years. 2. Body weight 50 kg - 70 kg, BMI 18 - 28 kg/m², calculated per Metropolitan Index 1983 for adults. 3. At the time of screening, the subject is determined to be healthy by the investigator through a general clinical examination. 4. Laboratory test results for ECG, hematology and biochemistry (fasting glucose, urea, AST, ALT, creatinine) are within normal limits or assessed by the investigator as normal/eligible for study participation. 5. Screening test results: * Hemoglobin 125-175 g/L; * Vitamin B12 200-300 pg/mL; * Ferritin 22-400 ng/mL; * Transferrin 200-360 mg/dL; * Albumin 35-52 g/L; * Reticulocytes, red blood cells, and platelets within normal range; * Negative urine drug screen; * Negative HBsAg, anti-HCV and HIV. 6. Voluntarily participates in the study and has signed the informed consent form. Exclusion Criteria: 1. Lacks civil act capacity. 2. History of severe allergic reaction or anaphylaxis to biological products. 3. Use of Erythropoiesis Stimulating Agents (ESAs) or immunoglobulins within 3 months prior to screening. 4. History of seizures, epilepsy, or current disorders of the cardiovascular, respiratory, hepatic, renal, gastrointestinal, immune, hematologic, endocrine, nervous system, or psychiatric illness (as determined by the examining physician). 5. Recent illness within 2 weeks prior to screening (based on medical history and clinical examination). 6. History of blood loss \>450 mL or blood donation within 28 days prior to the first scheduled dose. 7. History of illicit drug use. 8. Recent history of alcohol abuse (defined as regular alcohol consumption within 6 months prior to screening, with average weekly intake \>21 units/week. One unit equals 8 g ethanol, equivalent to: 240 mL (half a glass) of beer, or 100 mL (1 glass) of wine, or 25 mL (1 shot) of spirits). 9. Recent history of tobacco abuse (defined as smoking on average \>10 cigarettes/day within 3 months prior to screening, or inability to abstain from smoking throughout the study period). 10. Excessive caffeine consumption (more than 5 cups of coffee per day). 11. Special dietary habits or inability to consume meals provided by the study site. 12. Currently participating in another clinical study, or has participated in a clinical study with another investigational product within the last 3 months. 13. Planning to conceive during the study period or unwilling to use contraception throughout the study.

Clinical Research Directory

Pharmacokinetics, Pharmacodynamics, and Safety of NANOKINE Compared With Eprex 4000 U in Healthy Volunteers

Summary

Key Details

Conditions

Interventions

Eligibility Criteria