Clinical Trials Directory

Trials / Completed

CompletedNCT06100900

Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)

An Open-Label, Multicenter, Intra-Subject Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Therapeutic Potential of BCX10013 in Subjects with Paroxysmal Nocturnal Hemoglobinuria

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
8 (actual)
Sponsor
BioCryst Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a multicenter, open-label, intra-subject, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of BCX10013 in participants with PNH. Approximately 8 participants will be enrolled in this study. Participants may receive treatment for up to 52 weeks.

Conditions

Interventions

TypeNameDescription
DRUGBCX10013Multiple dose levels may be tested in this study.

Timeline

Start date
2023-10-24
Primary completion
2024-12-11
Completion
2024-12-11
First posted
2023-10-25
Last updated
2025-01-08

Locations

4 sites across 2 countries: Malaysia, South Africa

Source: ClinicalTrials.gov record NCT06100900. Inclusion in this directory is not an endorsement.