drugset
drugset / Trial / NCT04330534

First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH

NCT04330534 ↗

Phase 1/2 Completed 168 enrolled BioCryst Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX9930 in healthy subjects and in subjects with paroxysmal nocturnal hemoglobinuria (PNH; Part 3). Pharmacokinetics is an analysis of how the body handles the study drug BCX9930 and pharmacodynamics is an analysis of the activity that the study drug BCX9930 may have in the body.

Timeline

Start
2020-03-03
Primary completion
2020-11-11
Completion
2021-01-25

Drugs

EvaluationDrugModalityDoseRoute
Subject BCX9930 Unknown — Oral

Indications

paroxysmal nocturnal hemoglobinuria