Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926819
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Hillhurst Biopharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: HBI-002 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 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 Ascending Dose Safety and Pharmacokinetic Study of HBI-002 Carbon Monoxide Oral Liquid Drug Product in Healthy Adult Volunteers.
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

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.




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to 7 days post last dose. ]
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

  2. Maximum COHb Concentration (Cmax). [ Time Frame: 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 :
  1. Number of Participants With Laboratory Test Abnormalities [ Time Frame: Day 1 to 7 days post last dose. ]
    Number of Participants With Laboratory Test Abnormalities

  2. Time to Maximum COHb Concentration (Tmax). [ Time Frame: 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).

  3. Elimination Half-Life (T1/2) [ Time Frame: 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)

  4. Area Under the Curve (AUC) [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Layout table for additonal information
Responsible Party: Hillhurst Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03926819    
Other Study ID Numbers: HBI-CP-01-001
2R44HL131065 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hillhurst Biopharmaceuticals, Inc.:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Carbon Monoxide
CO
Heme Oxygenase
HO-1
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs