At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
HBI-002drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Open Labeled Single Ascending Dose Followed by Multiple Dose Safety and Pharmacokinetic Study of HBI-002 Carbon Monoxide Oral Liquid Drug Product in Healthy Adult Volunteers.
In Brief
A Phase 1 clinical trial evaluating HBI-002 for Anemia, Sickle Cell. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This is a single center, open label Phase 1 clinical trial in normal adult subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of HBI-002, an orally administered liquid containing carbon monoxide (CO), with single ascending doses (SAD), followed by multiple dose with doses daily for 7 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia, Sickle Cell
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartJul 2022
Primary CompletionApr 2023
TodayJul 2026
First PostedApr 25, 2019
Enrollment StartJul 25, 2022
Primary CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.2 years ago
Interventions
HBI-002drug
Oral liquid carbon monoxide drug product.