RBR-78vysg
Not yet recruiting
Phase 1
Phase I, monocentric, open-label clinical trial to determine the pharmacokinetics and pharmacodynamics of subcutaneous recombinant human erythropoietin in healthy adult male population
aboratório Daudt Oliveira Ltda.0 sitesOctober 30, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Anemia
- Sponsor
- aboratório Daudt Oliveira Ltda.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed Consent Form approved by IRB signed; male; age between 18 and 55 years; be characterized as a healthy research participant from medical history, general physical examination and vital signs, laboratory tests and ECG indicating no evidence of disease; have a BMI equal or greater than 18 and equal or less than 29\.9 kg/m2; have a body weight of 60 \- 100 kg; normal iron metabolism tests
Exclusion Criteria
- •Cardiovascular disorders and BP greater than 145/90 mmHg; history of venous thrombosis; presence of iron deficiency anemia or clinical history of autoimmune or hereditary anemia; clinical history of chronic or acute bleeding in the 30 days before the start of the trial; prior erythropoietin therapy; signs or clinical history of spinal cord aplasia; changes in the electrocardiogram that, at the physician's discretion, does not recommend the participant's stay in the trial; have a history of excessive alcohol consumption for at least 6 months prior to the trial (drinking 5 or more alcoholic beverages in one day or 15 or more alcoholic beverages per week); be a smoker or have quit smoking for less than 6 months; participant who consumes 5 or more cups of tea or coffee per day and cannot abstain during the trial period; participants with chronic diseases; hypersensitivity or contraindication of using the components of the medications studied; blood donation (more than 500 mL) or major surgery within 3 months prior to signing the Informed Consent Form; participation in clinical trial protocols in the last 12 months; any clinical condition or laboratory abnormality which, at the discretion of the investigator, could compromise trial participation
Outcomes
Primary Outcomes
Not specified
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