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Carbon Monoxide Therapeutic

Multiple Ascending Dose for Sickle Cell Anemia

Phase 1
Waitlist Available
Research Sponsored by Hillhurst Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 7 days post last dose.
Awards & highlights

Study Summary

This trial is testing a new drug, HBI-002, which contains carbon monoxide. The trial will test how safe and tolerable the drug is in normal adults, as well as how the body processes and responds to the drug.

Eligible Conditions
  • Sickle Cell Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 7 days post last dose.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 7 days post last dose. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum COHb Concentration (Cmax).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Area Under the Curve (AUC)
Elimination Half-Life (T1/2)
Number of Participants With Laboratory Test Abnormalities
+1 more

Trial Design

2Treatment groups
Active Control
Group I: Multiple Ascending DoseActive Control1 Intervention
Group II: Single Ascending DoseActive Control1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,607 Total Patients Enrolled
26 Trials studying Sickle Cell Anemia
2,458 Patients Enrolled for Sickle Cell Anemia
Hillhurst Biopharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risk is associated with the Single Ascending Dose approach?

"As this is a phase 1 trial, with limited data on its efficacy and safety, Single Ascending Dose receives a rating of 1."

Answered by AI

Who is the optimal group of participants for this clinical study?

"This clinical trial is accepting twenty individuals between 18 and 55 years of age with anemia or sickle cell. Participants must meet the following stipulations: total bilirubin not exceeding 1.5 times normal, carboxyhemoglobin level via venous blood gas ≤ 3.5%, signed consent form upon enrollment, negative tests for HBsAg, aHCV, aHIV and SARS-CoV-2 prior to medication intake , non smoker/vaper (no use of tobacco or marijuana products within three months before screening), no clinically significant hematological, renal, endocrine pulmonary gastrointestinal cardiovascular hepatic psychiatric"

Answered by AI

What are the anticipated outcomes of this experiment?

"The primary metric of this trial is the number of participants that experience treatment-emergent adverse events or serious adverse events. Secondary objectives include measuring time to maximum carboxyhemoglobin concentration, elimination half-life and any laboratory test abnormalities. Blood samples will be taken before and after dosing at various intervals up to 72 hours post administration."

Answered by AI

Are any participants aged 20 or older accepted into this experiment?

"This medical trial has an age requirement that ranges from 18 to 55 years old."

Answered by AI

What is the current enrollment figure for participants in this trial?

"Affirmative. Clinicaltrials.gov attests that this research project, initially published on July 25th 2022, is actively engaging participants. The trial calls for 20 individuals to join from a single medical site."

Answered by AI

Is this research endeavor accepting participants currently?

"Affirmative. The clinical trial is actively seeking volunteers, as documented on the clinicaltrials.gov platform; which initially posted the study on July 25th 2022 and provided an update to this information by October 25th of that same year. 20 participants are needed for 1 location."

Answered by AI
~7 spots leftby Apr 2025