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Gas Therapy

Oral Carbon Monoxide Therapy for Sickle Cell Anemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Hillhurst Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight: For 18 years of age and above, between 45 kg and 110 kg (inclusive) and with body mass index (BMI) less than 30 kg/m2. For 14 to 18 years of age, above 35 kg and with BMI less than 30 kg/m2
Male or female 14-55 years of age inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a liquid containing carbon monoxide to treat sickle cell disease. It looks at safety, how the body processes it, and how it works.

Who is the study for?
This trial is for non-smoking individuals aged 14-55 with sickle cell disease. Participants must have a stable weight and BMI, normal heart function, and no significant medical issues. Women must not be pregnant and all participants should agree to use effective contraception during the study.
What is being tested?
The trial tests HBI-002, an oral liquid carbon monoxide treatment for sickle cell disease. Over two weeks, its safety, how well it's tolerated by patients' bodies (tolerability), how the body processes it (pharmacokinetics), and how it affects the disease (pharmacodynamics) are studied.
What are the potential side effects?
While specific side effects of HBI-002 are not listed here, common concerns may include reactions at the administration site or general symptoms like headache or nausea. The study aims to identify any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18+ years old, weigh between 45-110 kg, and my BMI is under 30 OR I am 14-18 years old, weigh above 35 kg, and my BMI is under 30.
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I am between 14 and 55 years old.
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My blood counts and clotting tests are within the required ranges.
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My heart is healthy based on recent tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ascending Multiple DoseExperimental Treatment1 Intervention
Drug: HBI-002 (oral liquid carbon monoxide drug product)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HBI-002
2022
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,313 Total Patients Enrolled
Hillhurst Biopharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
~5 spots leftby Nov 2025
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