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A Phase I Dose Escalation Study of Harmine in Healthy Subjects PI: James Murrough, MD, PhD NCT05526430 Document Date: June 6, 2023THE MOUNT SINAI HEALTH SYSTEM CONSENT FORM TO VOLUNTEER IN A RESEARCH
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Prepare all necessary materials and documentation required for the phase I dose.
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Review the protocol and inclusion/exclusion criteria for patient eligibility.
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Calculate the appropriate dose based on the study design and patient characteristics.
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Obtain informed consent from the patient participating in the study.
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Administer the phase I dose as per the safety guidelines and monitoring requirements.
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A Phase I dose refers to the initial amount of a drug administered in the first stage of clinical trials, primarily to assess safety, tolerability, and pharmacokinetics in a small group of healthy volunteers or patients.
Researchers, pharmaceutical companies, or any organization conducting clinical trials on new drugs are required to file a Phase I dose with regulatory authorities to obtain approval before starting the trial.
To fill out a Phase I dose, investigators must provide detailed information including the drug formulation, dose levels, administration route, study design, eligibility criteria, and informed consent procedures.
The purpose of a Phase I dose is to evaluate the safety and tolerability of a drug in humans, establish dosing parameters for future phases, and identify any potential side effects or adverse reactions.
Information that must be reported includes the drug's chemical properties, proposed dosage, patient selection criteria, monitoring procedures, safety assessments, and potential risks associated with the treatment.
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