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Pharmacokinetics and Pharmacodynamics in Healthy VolunteersPhase 1NCT06919861

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

A Phase 1 study testing Erythropoietin alfa in people with Pharmacokinetics and Pharmacodynamics in Healthy Volunteers, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
Erythropoietin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
No sites listed yet
Study dates
Sep 2026to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

About this study

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

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.

Read more

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.

Read the detailed description

Erythropoietin (EPO) is a glycoprotein hormone essential for red blood cell (RBC) formation, primarily produced in the kidneys. Recombinant human erythropoietin (rHuEPO) or erythropoiesis-stimulating agents (ESAs) are used to treat anemia in chronic renal failure, chemotherapy-induced anemia, and to reduce transfusion needs in surgery.

Nanokine, currently considered as a follow-on biological product of Eprex® developed by Nanogen Biopharmaceutical JSC, is produced in CHO cells. This study evaluates the bioequivalence of Nanokine and Eprex® in healthy volunteers, comparing pharmacokinetics (PK), pharmacodynamics (PD), and safety.

A randomized, open-label, single-dose, two-sequence crossover trial is conducted in 44 healthy male volunteers (aged 19-45 years, BMI 18.0-28.0 kg/m²). Participants received a 4,000 IU subcutaneous injection of either Eprex® or Nanokine, followed by the alternate after a 28-day washout. Blood samples for PK analysis were taken at multiple time points up to 144 hours postdose, while PD markers (reticulocytes) were measured up to 312 hours postdose.

The purpose of this clinical study is to evaluate and compare the pharmacokinetics, pharmacodynamics, and safety profile of NANOKINE (manufactured by Nanogen Pharmaceutical Biotechnology Joint Stock Company) with Eprex 4000 U (manufactured by Cilag AG).

This is a randomized, two-treatment, two-period, crossover study involving a single-dose subcutaneous injection administered to healthy volunteers.

Participants will undergo a comprehensive screening process to ensure they are in good health, meet the required age range of 18 to 45 years, and fall within the specified body weight and body mass index (BMI) criteria. Eligible subjects will be randomly assigned to receive the study treatments across two distinct periods, separated by a washout phase, to evaluate how each product behaves in the body and to assess their overall safety and tolerability.

Pharmacokinetics (PK) Statistical Hypotheses:

  • Null Hypothesis (H0): The 90% confidence interval of the geometric mean ratio (GMR) between NANOKINE and Eprex 4000 U for the log-transformed data of AUC0-t and Cmax falls outside the bioequivalence limits of 80.00% to 125.00%.
  • Alternative Hypothesis (H1): The 90% confidence interval of the GMR falls within the limits of 80.00% to 125.00% for the log-transformed data of both AUC0-t and Cmax, thereby demonstrating pharmacokinetic equivalence between the two formulations.

Pharmacodynamics (PD) Statistical Hypotheses:

  • Null Hypothesis (H0): The 90% confidence interval of the geometric mean ratio (GMR) between NANOKINE and Eprex 4000 U for the log-transformed data of AUC0-t and Cmax of reticulocyte (RET) count falls outside the bioequivalence limits of 80.00% to 125.00%.
  • Alternative Hypothesis (H1): The 90% confidence interval of the GMR falls within the limits of 80.00% to 125.00% for the log-transformed data of both AUC0-t and Cmax of reticulocyte (RET) count, thereby demonstrating pharmacodynamic equivalence between the two formulations.

This study is conducted at the Center for Clinical Pharmacology, Hanoi Medical University, in accordance with the Vietnam Biomedical Research, Ethics, and Regulatory Guidelines.

Being tested
Erythropoietin alfa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erythropoietin alfaBiological

    Also called Nanokine

    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.

  • Erythropoietin alfaBiological

    Also called Eprex

    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.

Study groups in NCT06919861
Study groupRoleWhat they receive
Nanokine 4000 IUExperimentalNanokine 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.
Receives: Biological: Erythropoietin alfa
Eprex 4000 UActive comparatorEprex 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.
Receives: Biological: Erythropoietin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-t

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

    Measured: 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)

  2. Cmax

    Peak plasma concentration

    Measured: 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).

  3. AUC0-t of RET

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

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

  4. Cmax of RET

    Maximum Observed Effect of Reticulocyte Count (Cmax of RET)

    Measured: 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)

  1. AUC0-inf

    Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)

    Measured: 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)

  2. Tmax

    Time to Maximum Observed Plasma Concentration (Tmax)

    Measured: 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)

  3. T1/2

    Plasma Elimination Half-Life (T1/2)

    Measured: 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)

  4. CL.obs

    Apparent Clearance (CL.obs)

    Measured: 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)

  5. Vz.obs

    Apparent Volume of Distribution (Vz.obs)

    Measured: 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).

  6. Lambda.z

    Terminal Elimination Rate Constant (Lambda.z)

    Measured: 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)

  7. RBC Count

    Red Blood Cell (RBC) Count

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

  8. Hb

    Hemoglobin (Hb)

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

  9. Adverse events

    Adverse events (AE); Serious adverse events (SAE); Other safety assessments such as vital signs, testing, and examination.

    Measured: Baseline to 312 hours after the crossover dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2025
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06919861
Sponsor's protocol ID
NNG31
Status last verified
Jul 2026
First submitted
26 Mar 2025
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erythropoietin alfa in people with Pharmacokinetics and Pharmacodynamics in Healthy Volunteers, run by Nanogen Pharmaceutical Biotechnology Joint Stock Company.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-t (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06919861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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