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AzTrials

Anemia, Sickle CellPhase 2NCT06144749

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

A Phase 2 study testing HBI-002 in people with Anemia, Sickle Cell, run by Hillhurst Biopharmaceuticals, Inc. at 2 sites in Panama.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Anemia, Sickle Cell
What is being tested?
HBI-002
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesPanama
Study dates
15 Feb 2025to 30 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to 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. 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:
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  • ≤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.
  • Subjects 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 the inclusion to this study.
  • 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 including liver and kidney function, as determined by the Investigator.
  • 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 documented as stable or not clinically significant changes over the period between screening and baseline.
  • Negative pregnancy test for females.
  • Subjects 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 subjects, 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 progesterone, subdermal implant if the female partner could become pregnant.
  • Female subjects 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 contraceptive, injectable progesterone, subdermal implant, and be instructed that their male partners should use a condom, if not vasectomized.

Who cannot join

  • 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.
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  • 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 discontinued 14 days prior to dosing. Prescribed analgesics for regular self-administration are permitted provided that dosing of such has not been increased or new drugs added over the past 7 days.
  • 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 100 bpm or arrhythmia) at screening and/or baseline, as determined by the Investigator. Heart rate corrected QT interval-Frederica's method (QTcF) >450 msec male, >470 msec female.
  • 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 interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
  • 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.

Trial locations and contacts

2 sites in 1 country.

Panama2 sites

  • Cevaxin - The Panama Clinic

    Panama City

  • Hospital Pacífica Salud

    Panama City

Other trials in Panama

About this study

Official title: 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.

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.

Being tested
HBI-002
Keywords
Anemia, Sickle Cell, Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia, Hematologic Diseases, Hemoglobinopathies, Genetic Diseases, Inborn, Carbon Monoxide, CO, Heme Oxygenase, HO-1
Medical subject headings
Anemia, Sickle Cell, Anemia, Hemolytic, Hematologic Diseases, Hemoglobinopathies, Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HBI-002Drug

    Oral liquid carbon monoxide drug product.

Study groups in NCT06144749
Study groupRoleWhat they receive
Ascending Multiple DoseExperimentalDrug: HBI-002 (oral liquid carbon monoxide drug product)
Receives: Drug: HBI-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of Treatment Emergent Adverse Events, including adverse events of special interest

    Measured: Day 1 to 44

Secondary outcomes (5)

  1. Maximum caboxyhemoglobin concentration (Cmax) as measured by carboxyhemoglobin (COHb) saturation

    Measured: Days 1 and 4

  2. Elimination half-life (t1/2) as measured by COHb saturation

    Measured: Days 1 and 4

  3. Change from baseline in complete blood count (CBC) test parameters, including hemoglobin, hematocrit, red blood cell (RBC) count, white blood cell (WBC) count, and neutrophil count

    Measured: Day 0 to 15

  4. Change from baseline in inflammation and oxidation, as assessed by levels of protein and/or mRNA indicators, particularly those associated with heme oxygenase-1 (HO-1)

    Measured: Day 0 to 15

  5. Change from baseline in patient pain levels as measured by an emoji faces pain scale with pain assessment from 0 to 10 and with higher scores indicating more severe pain

    Measured: Days 1 to 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start15 Feb 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06144749
Sponsor's protocol ID
HBI-002-121
Other IDs
2R44HL131065-05
Status last verified
Aug 2026
First submitted
10 Nov 2023
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HBI-002 in people with Anemia, Sickle Cell, run by Hillhurst Biopharmaceuticals, Inc. at 2 sites in Panama.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of Treatment Emergent Adverse Events, including adverse events of special interest (time frame: Day 1 to 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06144749.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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