A phase I double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of ascending single doses of ANF-Rho in comparison to standard of care-Neulasta® in healthy volunteers

Completed

• Conditions: shortage of white blood cells; 10047954

• Registration Number: NL-OMON41975
• Lead Sponsor: Prolong Pharmaceuticals, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 83

Inclusion Criteria

healthy male/female subjects
18-55 yrs, inclusive
BMI: 18.0-30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 12 weeks from the start of the study. In case of donating more than 1.5 liters of blood (for men) or 1.0 liter of blood (for women) in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the plasma pharmacokinetic profiles of ANF-Rho at ascending single<br /><br>dose in healthy volunteers in comparison to Neulasta® (SOC).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic:<br /><br>-To determine the effect on absolute neutrophil counts (ANC) and CD 34+ cells<br /><br>in increasing doses of ANF-Rho in healthy volunteers in comparison to placebo<br /><br>and Neulasta®.<br /><br><br /><br>To assess the immunogenicity potential of ANF-Rho by measuring antibodies and<br /><br>neutralizing antibodies to ANF-Rho following a single subcutaneous dose.<br /><br><br /><br>To assess the occurrence and severity on bone pain in increasing doses of<br /><br>ANF-Rho in healthy volunteers in comparison to placebo and Neulasta®.</p><br>