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

NCT06919861 | Not Yet Recruiting Phase 1

• 1 other identifier: NNG31
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pharmacokinetics and Pharmacodynamics in Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• AUC0-t

  Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)

• Cmax

  Peak plasma concentration

  Pre-dose (30, 20, and 10 minutes before injection) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after injection).

• AUC0-t of RET

  Area Under the Effect-Time Curve of Reticulocyte Count (AUC0-t of RET)

  Pre-dose (10 minutes before administration) and post-dose (12, 24, 48, 72, 96, 120, 144, 168, 216, and 312 hours after administration)

• Cmax of RET

  Maximum Observed Effect of Reticulocyte Count (Cmax of RET)

  Pre-dose (10 minutes before administration) and post-dose (12, 24, 48, 72, 96, 120, 144, 168, 216, and 312 hours after administration)

Secondary Outcomes (9)

• AUC0-inf

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)

• Tmax

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)

• T1/2

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)

• CL.obs

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration)

• Vz.obs

  Pre-dose (30, 20, and 10 minutes before administration) and post-dose (30 minutes, 3, 6, 9, 12, 14, 15, 24, 30, 48, 72, 96, 120, and 144 hours after administration).

Study Arms (2)

Nanokine 4000 IU

EXPERIMENTAL

Nanokine 4000 IU, prefilled syringe, subcutaneous injection. Nanokine 4000 IU will be transported and handed over to the Study Center by the Sponsor. Nanokine 4000 IU should be stored in a refrigerator of 2-8°C.

Biological: Erythropoietin alfa

Eprex 4000 U

ACTIVE COMPARATOR

Eprex 4000 U, pre-closed syringe, subcutaneous injection. Eprex 4000 U will be transported and handed over directly to the Study Center by the supplier (with a contract with the Sponsor). Eprex 4000 U should be stored in a refrigerator of 2- 8 °C.

Biological: Erythropoietin alfa

Interventions

Erythropoietin alfa BIOLOGICAL

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.

Also known as: Nanokine

Eprex 4000 U; Nanokine 4000 IU

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, aged 18 to 45 years.
• Body weight 50 kg - 70 kg, BMI 18 - 28 kg/m², calculated per Metropolitan Index 1983 for adults.
• At the time of screening, the subject is determined to be healthy by the investigator through a general clinical examination.
• 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.
• 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.
• Voluntarily participates in the study and has signed the informed consent form.

You may not qualify if:

• Lacks civil act capacity.
• History of severe allergic reaction or anaphylaxis to biological products.
• Use of Erythropoiesis Stimulating Agents (ESAs) or immunoglobulins within 3 months prior to screening.
• 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).
• Recent illness within 2 weeks prior to screening (based on medical history and clinical examination).
• History of blood loss \>450 mL or blood donation within 28 days prior to the first scheduled dose.
• History of illicit drug use.
• 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).
• 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).
• Excessive caffeine consumption (more than 5 cups of coffee per day).
• Special dietary habits or inability to consume meals provided by the study site.
• Currently participating in another clinical study, or has participated in a clinical study with another investigational product within the last 3 months.
• Planning to conceive during the study period or unwilling to use contraception throughout the study.

Sponsors & Collaborators

• Nanogen Pharmaceutical Biotechnology Joint Stock Company: lead

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07