A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Thera… (NCT06144749) | Clinical Trial Compass
CompletedPhase 2
A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD)
Panama13 participantsStarted 2025-02-15
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent.
. Male or female 14-55 years of age inclusive.
. Negative Hepatitis B surface antigen (HBsAg), anti-Hepatitis C (aHCV), anti-Human Immunodeficiency Virus (aHIV), and SARS-CoV-2 test. Subjects that test SARS-CoV-2 positive at screen or baseline can be re-screened at least four weeks after the positive test so long as they are asymptomatic and test negative.
. Non-smoker or vaper (no use of tobacco or marijuana products within 3 months of screening).
. 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.
. Established Hb-SS or Sβ0 SCD with:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency and severity of Treatment Emergent Adverse Events, including adverse events of special interest
. ≤10 vaso-occlusive crises (VOC) per year over the prior two years; and
. a history of one or more episodes of one of the following: acute chest syndrome, stroke, priapism, bone avascular necrosis, or splenic sequestration.
Exclusion criteria
. Hemoglobinopathy other than SCD or S/beta 0 thalassemia.
. Clinical, ECG or laboratory evidence of cardiac dysfunction as determined by the PI.
. Acute chest syndrome or VOC within 21 days or signs or symptoms of an impending vaso-occlusive crisis as determined by both the subject and PI immediately prior to first dosing with HBI-002/placebo.
. Current smoker.
. Clinically significant illness or surgery other than that associated with SCD within 3 months prior to dosing.
. Blood transfusion within six weeks prior to the first administration of study drug.
. Exposure to any live vaccine within 28 days prior to study drug administration.
. History of febrile or infective illness within 14 days prior to dosing.