A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers

Sponsor

Hillhurst Biopharmaceuticals, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT03926819

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a single center, open label Phase 1 clinical trial in normal adult subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of HBI-002, an orally administered liquid containing carbon monoxide (CO), with single ascending doses (SAD), followed by multiple dose with doses daily for 7 days.

Condition or Disease	Intervention/Treatment	Phase
Anemia, Sickle Cell	Drug: HBI-002	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Open Labeled Single Ascending Dose Followed by Multiple Dose Safety and Pharmacokinetic Study of HBI-002 Carbon Monoxide Oral Liquid Drug Product in Healthy Adult Volunteers.

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single Ascending Dose	Drug: HBI-002 Oral liquid carbon monoxide drug product.
Active Comparator: Multiple Ascending Dose	Drug: HBI-002 Oral liquid carbon monoxide drug product.

Arm

Intervention/Treatment

Active Comparator: Single Ascending Dose

Drug: HBI-002

Oral liquid carbon monoxide drug product.

Active Comparator: Multiple Ascending Dose

Drug: HBI-002

Oral liquid carbon monoxide drug product.

Outcome Measures

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Day 1 to 7 days post last dose.]
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Maximum COHb Concentration (Cmax). [Blood samples will be drawn on Day 1 immediately before and after dosing at 30, 60, 90, 120 minutes and at 3, 4, 5, 6, 24, 48, and 72 hours]
Maximum COHb Concentration (Cmax).

Secondary Outcome Measures

Number of Participants With Laboratory Test Abnormalities [Day 1 to 7 days post last dose.]
Number of Participants With Laboratory Test Abnormalities
Time to Maximum COHb Concentration (Tmax). [Blood samples will be drawn on Day 1 immediately before and after dosing at 30, 60, 90, 120 minutes and at 3, 4, 5, 6, 24, 48, and 72 hours]
Time to Maximum COHb Concentration (Tmax).
Elimination Half-Life (T1/2) [Blood samples will be drawn on Day 1 immediately before and after dosing at 30, 60, 90, 120 minutes and at 3, 4, 5, 6, 24, 48, and 72 hours]
Elimination Half-Life (T1/2)
Area Under the Curve (AUC) [Blood samples will be drawn on Day 1 immediately before and after dosing at 30, 60, 90, 120 minutes and at 3, 4, 5, 6, 24, 48, and 72 hours]
Area Under the Curve (AUC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Non-smoker (no use of tobacco or marijuana products within 3 months of screening)
Subjects must be healthy as defined by:
the absence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.
the absence of current clinically relevant abnormalities
the absence of clinically significant illness and/or surgery within 4 weeks prior to dosing.
Negative urine pregnancy test for females

Exclusion Criteria:

Anemia of any cause.
Homozygous or heterozygous hemoglobinopathy.
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 treatment.
History of febrile or infective illness within10 days preceding study drug treatment.
Weight loss or gain of more than 5 kg within 3 months of screening.
History of alcohol abuse or dependence or regular use of alcohol within six months prior to the screening visit (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 pulmonary infiltrate or pneumonia within 6 months before screening or pulmonary/bronchial infection within 2 weeks of screening.
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 drug abuse or dependence.
Use of prescription drugs within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal and vitamin supplements must be discontinued 28 days prior to the first dose of study medication.
Unwilling or unable to comply with the requirements of the protocol.
Any coincident disease or condition that in the opinion of the investigator would make the subject inappropriate for entry into the study or will confound the assessment of safety
Pregnancy or breast feeding.
Treatment with an investigational drug within the longer of 30 days or five half-lives of an investigational agent.