New anemia drug candidate put to the test against market leader
NCT ID NCT06919861
First seen Jul 07, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This trial compares a new erythropoietin drug called Nanokine to the approved drug Eprex in healthy male volunteers. The goal is to see if Nanokine is absorbed and processed by the body similarly to Eprex, and whether it has a comparable effect on red blood cell production. Each volunteer receives a single injection of both drugs, one after a 28-day break, and researchers measure drug levels and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Erythropoietin alfa (Nanokine and Eprex)
- What this could lead to
- If Nanokine proves similar to Eprex, it could become a more affordable alternative for treating anemia.
- What could go wrong
- This is an early-phase study in healthy volunteers, so results may not predict effects in patients with anemia. The drug may still fail in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.