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Multiple Ascending Dose for Sickle Cell Anemia
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.
- Sickle Cell Anemia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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