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

• Status: Not yet recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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, with single ascending doses (SAD), followed by multiple dose with doses daily for 7 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hillhurst Biopharmaceuticals, Inc.
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Carbon Monoxide

Criteria

Inclusion Criteria:

1. Non-smoker (no use of tobacco or marijuana products within 3 months of screening)

2. Subjects must be healthy as defined by:

1. the absence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.

2. the absence of current clinically relevant abnormalities

3. the absence of clinically significant illness and/or surgery within 4 weeks prior to dosing.

3. Negative urine pregnancy test for females

Exclusion Criteria:

1. Anemia of any cause.

2. Homozygous or heterozygous hemoglobinopathy.

3. Blood transfusion within six weeks prior to the first administration of study drug.

4. Exposure to any live vaccine within 28 days prior to study drug treatment.

5. History of febrile or infective illness within10 days preceding study drug treatment.

6. Weight loss or gain of more than 5 kg within 3 months of screening.

7. 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)

8. History of pulmonary infiltrate or pneumonia within 6 months before screening or pulmonary/bronchial infection within 2 weeks of screening.

9. History of cancer with the exception of adequately treated basal cell or squamous cell carcinoma of the skin more than 1 year prior.

10. History of drug abuse or dependence.

11. 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.

12. Unwilling or unable to comply with the requirements of the protocol.

13. 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

14. Pregnancy or breast feeding.

15. Treatment with an investigational drug within the longer of 30 days or five half-lives of an investigational agent.