NL-OMON41975CompletedNot Applicable
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 - ANF-Rho Phase I study in HV and comparability with Neulasta
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prolong Pharmaceuticals, LLC
- Enrollment
- 83
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
Investigators
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