Oral Carbon Monoxide Therapy for Sickle Cell Anemia

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hillhurst Biopharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Your carboxyhemoglobin level is 3.5% or lower before starting the study.

You must agree to use a very effective form of birth control during the study and for 30 days after it ends, if needed.

I am a man who will use a condom, and my partner will use another form of birth control.

+11 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Ascending Multiple DoseExperimental Treatment1 Intervention

Drug: HBI-002 (oral liquid carbon monoxide drug product)