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

NCT03926819 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HBI-002-0012R44HL131065
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell

Keywords

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Carbon Monoxide; CO; Heme Oxygenase; HO-1

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Day 1 of dosing, up to 30 days post-dose for SAD cohorts. Day 1 of dosing to 30 days post last dose, up to 37 days for MAD cohort

• Cmax

  Maximum COHb Concentration (Cmax), measured by blood gas machine with co-oximetry

  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

Study Arms (2)

Single Ascending Dose

ACTIVE COMPARATOR

Drug: HBI-002

Multiple Ascending Dose

ACTIVE COMPARATOR

Drug: HBI-002

Interventions

HBI-002 DRUG

Oral liquid carbon monoxide drug product.

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent.
• Healthy male or female 18-55 years of age inclusive.
• Negative HBsAg, aHCV, aHIV, and SARS-CoV-2 test.
• Non-smoker or vaper (no use of tobacco or marijuana products within 3 months of screening).
• Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2.
• Subjects must be healthy as defined by:
• absence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.
• liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤2 times the upper limit of the normal range
• total bilirubin ≤1.5 times the upper limit of the normal range
• renal function: creatinine clearance within normal range as assessed by Cockcroft and Gault calculation
• carboxyhemoglobin level by venous blood gas ≤ 3.5% (any time prior to the first dose)
• venous lactate level \<2.0 mmol/L at baseline.
• the absence of current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests (hematology and clinical chemistries), as determined by the Investigator.
• Negative pregnancy tests for females.
• Subjects must be willing to use a highly effective method of contraception for the duration of the study and for 30 days thereafter.

You may not qualify if:

• Subjects who meet any of the following criteria will be ineligible for participation in the study:
• Subjects with concurrent illness/disease as defined by:
• clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, as determined by the Investigator.
• current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests (hematology, clinical chemistries and urinalysis), as determined by the Investigator.
• clinically significant illness and/or surgery within 4 weeks prior to dosing.
• Anemia of any cause.
• Homozygous or heterozygous hemoglobinopathy.
• Blood transfusion within six weeks prior to the first administration of study drug.
• Carboxyhemoglobin ≥ 3.5% (any time prior to the first dose)
• Oxygen saturation by transcutaneous measurement consistently ≤ 95% (any time prior to the first dose)
• Exposure to any live vaccine within 28 days prior to study drug administration.
• History of febrile or infective illness within 14 days prior to dosing.
• Positive pregnancy test or breast feeding for females.
• Weight loss or gain of more than 5 kg within 3 months prior to dosing.
• History of alcohol abuse or dependence or regular use of alcohol within six months prior to dosing (defined as more than 14 units of alcohol per week; 1 Unit= 150 mL wine, 360 mL beer or 45 mL of 40% alcohol)

Sponsors & Collaborators

• Hillhurst Biopharmaceuticals, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Contact Company

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: President and CEO
• Organization: Hillhurst Bio

admin@hillhurstbio.com

858 232 9495

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: July 25, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)