First Study of AVI-014, a New G-CSF in Healthy People
Author Information
Author(s): Varki Roslyn, Pequignot Ed, Leavitt Mark C, Ferber Andres, Kraft Walter K
Primary Institution: Thomas Jefferson University
Hypothesis
AVI-014 has comparable safety and pharmacokinetic properties to filgrastim in healthy volunteers.
Conclusion
AVI-014 has safety, pharmacokinetic, and pharmacodynamic properties comparable to filgrastim at an equal dose in healthy volunteers.
Supporting Evidence
- AVI-014 demonstrated a side effect profile similar to that of filgrastim.
- Pharmacodynamic bioequivalence for WBC and ANC between AVI-014 and filgrastim was met.
- No serious adverse events were reported during the study.
Takeaway
AVI-014 is a new medicine that helps increase white blood cells, and it works similarly to an existing treatment called filgrastim.
Methodology
40 healthy volunteers received a single subcutaneous injection of either AVI-014 or filgrastim, and their responses were measured over time.
Potential Biases
Potential bias due to the lack of blinding in some treatment groups.
Limitations
The study did not include a formal power calculation and used a parallel design instead of a crossover design.
Participant Demographics
Mean age was 34.5 years, with 73% male, 32.5% white, and 67.5% black.
Statistical Information
Confidence Interval
90% CI: 0.76, 1.31 for AUC(0–72) at 4 mcg/kg
Digital Object Identifier (DOI)
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