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Official Title:
A Randomized, DoubleClick Phase 1 Safety and
Pharmacokinetic Study of Griffiths Enema Administered
Rectally to HIV1 Seronegative Adults
ClinicalTrials.gov ID (NCT number):
NCT04032717
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How to fill out a dose escalation study
How to fill out a dose escalation study
01
Determine the starting dose based on preclinical studies and available clinical data.
02
Define the escalation criteria, such as dose-limiting toxicities and maximum tolerated dose.
03
Identify the target patient population and enroll eligible participants.
04
Administer the starting dose to the first cohort of patients and monitor for adverse reactions.
05
If no dose-limiting toxicities are observed, escalate to the next dose level following the predefined escalation schedule.
06
Continue to monitor for safety and efficacy outcomes at each dose level.
07
Stop dose escalation once the maximum tolerated dose is reached or when the study objectives are met.
Who needs a dose escalation study?
01
Researchers looking to determine the safety and efficacy of a new drug or treatment
02
Pharmaceutical companies seeking regulatory approval for a new therapy
03
Clinicians interested in optimizing dosing regimens for individual patients
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What is a dose escalation study?
A dose escalation study is a clinical trial design in which investigational drugs are administered at increasing doses to determine the highest dose that can be safely tolerated.
Who is required to file a dose escalation study?
The sponsor or investigator conducting the clinical trial is required to file a dose escalation study.
How to fill out a dose escalation study?
A dose escalation study can be filled out by providing detailed information on the drug being investigated, the dosing schedule, any adverse events observed, and any dose-limiting toxicities.
What is the purpose of a dose escalation study?
The purpose of a dose escalation study is to identify the maximum tolerated dose of a drug, determine the safety profile, and establish the dosage regimen for further testing.
What information must be reported on a dose escalation study?
A dose escalation study must include information on the study design, dose escalation plan, inclusion/exclusion criteria, safety monitoring procedures, adverse event reporting, and data analysis plan.
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