Trial Outcomes & Findings for A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers (NCT NCT03926819)
NCT ID: NCT03926819
Last Updated: 2025-05-23
Results Overview
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
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
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Single Ascending Dose - 0.7 mg/kg
HBI-002: Oral liquid carbon monoxide drug product; adjusted.
|
Single Ascending Dose - 1.3 mg/kg
HBI-002: Oral liquid carbon monoxide drug product; adjusted.
|
Single Ascending Dose - 2.7 mg/kg
HBI-002: Oral liquid carbon monoxide drug product; adjusted.
|
Single Ascending Dose - 3.7 mg/kg
HBI-002: Oral liquid carbon monoxide drug product; adjusted.
|
Multiple Dose - 4.4, 3.6, 2.7 mg/kg
HBI-002: Oral liquid carbon monoxide drug product; dosing adjusted to achieve target range.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety and Pharmacokinetics of HBI-002, an Oral Carbon Monoxide Therapeutic, in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
SAD - 0.9 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 1.8 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 3.6 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 5.0 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Multiple Dose
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 8 • n=99 Participants
|
39 years
STANDARD_DEVIATION 12 • n=107 Participants
|
39 years
STANDARD_DEVIATION 9 • n=206 Participants
|
38 years
STANDARD_DEVIATION 7 • n=7 Participants
|
40 years
STANDARD_DEVIATION 8 • n=31 Participants
|
39 years
STANDARD_DEVIATION 8 • n=30 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
16 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 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 cohortNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Outcome measures
| Measure |
Single Ascending Dose - 0.9 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 1.8 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 3.6 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 5.0 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Multiple Dose
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Severe TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Moderate TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Mild TEAEs
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 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 hoursMaximum COHb Concentration (Cmax), measured by blood gas machine with co-oximetry
Outcome measures
| Measure |
Single Ascending Dose - 0.9 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 1.8 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 3.6 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Single Ascending Dose - 5.0 mg/kg
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
Multiple Dose
n=4 Participants
HBI-002: Oral liquid carbon monoxide drug product.
|
|---|---|---|---|---|---|
|
Cmax
|
3.4 percentage COHb saturation
Standard Deviation 0.1
|
3.8 percentage COHb saturation
Standard Deviation 0.5
|
5.7 percentage COHb saturation
Standard Deviation 1.7
|
6.9 percentage COHb saturation
Standard Deviation 1.6
|
8.7 percentage COHb saturation
Standard Deviation 1.3
|
Adverse Events
SAD - 0.9 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD - 1.8 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD - 3.6 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SAD - 5.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Multiple Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD - 0.9 mg/kg
n=4 participants at risk
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 1.8 mg/kg
n=4 participants at risk
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 3.6 mg/kg
n=4 participants at risk
HBI-002: Oral liquid carbon monoxide drug product.
|
SAD - 5.0 mg/kg
n=4 participants at risk
HBI-002: Oral liquid carbon monoxide drug product.
|
Multiple Dose
n=4 participants at risk
HBI-002: Oral liquid carbon monoxide drug product.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/4 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
0.00%
0/4 • 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
|
25.0%
1/4 • Number of events 2 • 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
|
50.0%
2/4 • Number of events 3 • 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
|
|
General disorders
General disorders and administration site conditions
|
0.00%
0/4 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
0.00%
0/4 • 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
|
25.0%
1/4 • Number of events 2 • 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
|
0.00%
0/4 • 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
|
|
Investigations
Investigations
|
25.0%
1/4 • Number of events 1 • 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
|
0.00%
0/4 • 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
|
0.00%
0/4 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
25.0%
1/4 • Number of events 1 • 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
|
|
Nervous system disorders
Nervous System Disorders
|
25.0%
1/4 • Number of events 1 • 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
|
0.00%
0/4 • 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
|
0.00%
0/4 • 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
|
75.0%
3/4 • Number of events 3 • 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
|
0.00%
0/4 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER