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Protocol Number: AVXS101CL102Official Title: Phase I, OpenLabel, Dose Comparison Study of AVXS101 for Sitting but Nonambulatory Patients with Spinal Muscular Atrophy NCT Number: NCT03381729Document

How to fill out phase i open-label dose

How to fill out phase i open-label dose

1. Obtain the phase I open-label study protocol from the sponsor or research organization.
2. Review the study objectives and the specific criteria for dosing.
3. Determine the patient population eligible for the study based on inclusion/exclusion criteria.
4. Identify the initial dose levels to be tested as outlined in the protocol.
5. Prepare the investigational product in accordance with regulatory standards.
6. Conduct informed consent discussions with potential participants and ensure their understanding.
7. Administer the initial dose to the first participant, following safety monitoring protocols.
8. Collect and document data on any adverse effects and treatment responses.
9. Analyze data periodically to determine the safety and tolerability of the dose.
10. Adjust dose levels as needed based on ongoing participant assessments and protocol guidelines.

Who needs phase i open-label dose?

1. Patients with specific medical conditions who are seeking new treatment options.
2. Researchers conducting clinical trials to assess the safety and efficacy of new drugs.
3. Regulatory bodies monitoring the progress of new drug development phases.
4. Pharmaceutical companies developing investigational drugs looking for initial feedback on dosing.

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What is phase i open-label dose?

Phase I open-label dose refers to the initial phase of a clinical trial where the drug is administered in an open-label manner to a small group of participants to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who is required to file phase i open-label dose?

Pharmaceutical companies or clinical research organizations conducting clinical trials are required to file phase I open-label dose information with regulatory authorities.

How to fill out phase i open-label dose?

To fill out a phase I open-label dose submission, researchers must provide detailed information about the study design, participant criteria, dosage regimen, safety monitoring plans, and the expected duration of the study.

What is the purpose of phase i open-label dose?

The purpose of phase I open-label dose is to determine the safety and appropriate dosage of a new medication while assessing its initial effects on the human body.

What information must be reported on phase i open-label dose?

Information that must be reported includes study objectives, participant demographics, dosing schedule, adverse events, lab results, and any preliminary efficacy observations.