PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag).
Recruiting
Phase 3
Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Incepta Pharmaceuticals Ltd · Industry
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About This Trial
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Erythropoietin, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous erythropoietin. Erythropoietin binds to the surface rec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* • Age ≥ 18 years.
* BMI of 18.0-30.0kg/m2.
* Voluntarily participants who agree to observe the precautions in writing after receiving a complete explanation of this trial.
* Willingness and ability to undertake all scheduled visits and assessments.
* Subject who have …
Contacts