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Tests treatment safety and results for Anemia, Sickle Cell
Official title A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD)
ClinicalTrials.gov ID: NCT06144749
What this study is testing
What is HBI-002?
HBI-002 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for anemia, sickle cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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. people that...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
Who can join
- 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. people that test SARS-CoV-2 positive at screen or baseline can be re-screened at...
- 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:
- ≤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.
- people may or may not be receiving hydroxyurea (HU) for SCD, but if receiving HU, they must be taking this medication according to physician instructions and without dose adjustment for a minimum of one month prior to...
- Normal cardiac function as evidenced by clinical, ECG and laboratory findings.
- Carboxyhemoglobin level by co-oximetry ≤ 3.5% (prior to first dose).
- The absence of current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical chemistries...
- Hematology including hemoglobin \>6g/dL, baseline white blood cell count \>7,000/uL and absolute neutrophil count (ANC) \>3,500/uL, platelet count \>80,000/uL and including coagulation labs (PT, PTT), with all levels...
- Negative pregnancy test for females.
- people must be willing to use a highly effective method of contraception for the duration of the study and for 30 days thereafter, if applicable.
- Male people, without a vasectomy, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable...
- Female people of childbearing potential (not surgically sterilized and less than one year post-menopausal) should use a form of contraception such as an intrauterine device (IUD), diaphragm with spermicide, oral...
What rules you out
- 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.
- Positive pregnancy test or breast feeding for females.
- Weight loss or gain of more than 5 kg within 3 months prior to dosing.
- History of alcohol abuse or dependence or regular use of alcohol within six months prior to dosing (defined as more than 14 units of alcohol per week; 1 Unit= 150 mL wine, 360 mL beer or 45 mL of 40% alcohol)
- History of renal dysfunction with glomerular filtration rate \<30 mL/min/1.73m2.
- History of pulmonary infiltrate or pneumonia within 6 months prior to dosing or pulmonary/bronchial infection within 2 weeks prior to dosing.
- Subject on domiciliary oxygen
- History of cancer, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin more than 1 year prior.
- History of cardiac disease.
- History of drug abuse, including administration of opioids for reasons other than pain control. Use of opioids for control of pain is permitted.
- Use of voxelotor or crizanlizumab or prescription drugs other than prescribed for SCD, within 7 days or 5 half-lives (whichever is longer) prior to dosing. Herbal and vitamin supplements (excluding L-glutamine) must be...
- Unwilling or unable to comply with the requirements of the protocol.
- Treatment with an investigational drug within the longer of 30 days or five half-lives.
- Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or above 140 mmHg, diastolic blood pressure lower than 50 or above 90 mmHg, or heart rate less than 45 or above...
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the...
- Any coincident disease or condition that in the opinion of the investigator will make the subject inappropriate for entry into the study or will confound the assessment of safety.
- History of allergic reactions to any of the drug product excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.