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

ClinicalTrials.gov ID: NCT03926819

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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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03926819
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Hillhurst Biopharmaceuticals, Inc.; Industry
Enrollment: 20 participants

Conditions and interventions

Conditions

Anemia, Sickle Cell

Interventions

HBI-002 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 25, 2022 (Actual)
Primary completion: Apr 26, 2023 (Actual)
Completion: Apr 26, 2023 (Actual)
Last update posted: May 23, 2025

2022 – 2023

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Contact Company	San Diego	California	92121	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03926819, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 23, 2025 · Synced Nov 15, 2026