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出境医 / 临床实验 / A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers

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

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, 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021
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.
Outcome Measures
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)


Eligibility Criteria
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.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date February 12, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: Day 1 to 7 days post last dose. ]
    Number of Participants With Laboratory Test Abnormalities
  • 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).
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers
Official Title  ICMJE 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.
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 dose with doses daily for 7 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Sickle Cell
Intervention  ICMJE Drug: HBI-002
Oral liquid carbon monoxide drug product.
Study Arms  ICMJE
  • Active Comparator: Single Ascending Dose
    Intervention: Drug: HBI-002
  • Active Comparator: Multiple Ascending Dose
    Intervention: Drug: HBI-002
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2021) 		20
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		28
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926819
Other Study ID Numbers  ICMJE HBI-CP-01-001
2R44HL131065 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hillhurst Biopharmaceuticals, Inc.
Study Sponsor  ICMJE Hillhurst Biopharmaceuticals, Inc.
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE Not Provided
PRS Account Hillhurst Biopharmaceuticals, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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