NCT06144749

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

An Open Label Phase 2a Ascending Multiple Dose Safety, Efficacy, and Pharmacokinetic Study of HBI-002 Carbon Monoxide Oral Liquid Drug Product in Adolescents and Adults With Sickle Cell Disease.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Hillhurst Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
DRUG	HBI-002	Oral liquid carbon monoxide drug product.

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-03-31
• Completion: 2026-06-30
• First posted: 2023-11-22
• Last updated: 2026-01-08

Locations

2 sites across 1 country: Panama

Regulatory

• FDA-regulated drug study