Pharmacokinetics, Pharmacodynamics, and Safety of Nanokine Produced by Nanogen Pharmaceutical Joint Stock Company

NCT06919861 | Not Yet Recruiting Phase 1 DMC

• 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, double-blind, two-sequence, crossover 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) markers (reticulocyte count, hematocrit, hemoglobin, and RBC 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

Natural Blood and Blood Product Toxicity

Outcome Measures

Primary Outcomes (2)

• AUC0-inf

  Area under the plasma concentration versus time curve from time 0 to infinity

  10 minutes before administration (day 1/day 29); 1, 2, 4, 6, 8, 10, 12, 14,16, 24, 36, 48, 72, 96, 120, 144 hrs after administration for each period]

• Cmax

  Peak plasma concentration

  10 minutes before administration (day 1/day 29); 1, 2, 4, 6, 8, 10, 12, 14,16, 24, 36, 48, 72, 96, 120, 144 hrs after administration for each period]

Secondary Outcomes (15)

• AUClast

  10 minutes before administration (day 1/day 29); 12, 24, 48, 72, 96, 120, 144, 216, 312 hrs after administration for each period]

• Clast.obs

  10 minutes before administration (day 1/day 29); 12, 24, 48, 72, 96, 120, 144, 216, 312 hrs after administration for each period]

• Tmax

  10 minutes before administration (day 1/day 29); 12, 24, 48, 72, 96, 120, 144, 216, 312 hrs after administration for each period]

• T1/2

  10 minutes before administration (day 1/day 29); 12, 24, 48, 72, 96, 120, 144, 216, 312 hrs after administration for each period]

• Tlast

  10 minutes before administration (day 1/day 29); 12, 24, 48, 72, 96, 120, 144, 216, 312 hrs after administration for each period]

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 IU

ACTIVE COMPARATOR

Eprex 4000 IU, pre-closed syringe, subcutaneous injection. Eprex 4000 IU will be transported and handed over directly to the Study Center by the supplier (with a contract with the Sponsor). Eprex 4000 IU 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 IU; Nanokine 4000 IU

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male aged between 18 and 45.
• Weight between 50 kg and 70 kg, BMI between 18 and 27 at the time of screening.
• Subjects of reproductive age must approve the use of effective contraception (such as oral contraceptives, intrauterine or implantable, intrauterine placement, physical methods, etc.) from screening until 6 months after the last dose.
• Signed an informed consent form to participate in the study.

You may not qualify if:

• Subjects who meet at least one of the following criteria will be excluded from the study:
• Use EPO (erythropoietin), darbepoetin, or another source of EPO protein, immunoglobulin, within 3 months before screening.
• History of severe allergic reactions or anaphylactic reactions to biological products.
• There are any clinically significant diseases such as high blood pressure, other cardiovascular diseases, psychiatry, cancer, acute and chronic respiration, diabetes, chronic inflammation (such as rheumatoid arthritis, lupus erythematosus, etc.), or autoimmune diseases.
• Having a history of red blood cell diseases such as thalassemia, sickle cell...
• Those who bled over 400mL or donated blood within 8 weeks of the scheduled first dose.
• People with screening results:
• Hemoglobin level below 12 g/dL or above 17 g/dL;
• Vitamin B12 level below 200 pg/mL;
• Ferritin level below 21.8 ng/mL;
• Transferrin level below 190 mg/dL;
• Albumin level below 3.5 g/dL or more than 4.8 g/dL;
• Reticulocyte, erythrocytes, platelets, or serum potassium level over the normal range
• Positive on the HIV antibody, HBsAg, HCV(Hepatitis C Virus) antibody tests.
• Those whose vital signs are measured in the sitting position after resting for 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.

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: June 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05