Clinical trial for the subcutaneous recombinant human erythropoietin biosimilar in healthy adult male populatio

Phase 1

• Conditions: Anemia; C15.378.071

• Registration Number: RBR-78vysg
• Lead Sponsor: aboratório Daudt Oliveira Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified