Clinical Trial

A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD)

Completed Phase 2
View on ClinicalTrials.gov →
Summary
This is a multi-center, open label Phase 2a clinical trial in subjects with sickle cell disease to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of HBI-002, an orally administered liquid containing carbon monoxide (CO), with doses daily for 14 days.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-07
critical Phase changed: Phase 1/2 -> Phase 2 2026-08-07
notable Enrollment increased: 9 -> 13 participants 2026-08-07
notable Primary completion pushed: 2026-03-31 -> 2026-06-30 2026-08-07
Trial Details
NCT Number NCT06144749
Lead Sponsor Hillhurst Biopharmaceuticals, Inc.
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Anemia, Sickle Cell
Enrollment 13 participants
Start Date 2025-02-15
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06