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PIKTOR (TAK228 + TAK117) Clinical Study Protocol X31025CLINICAL STUDY PROTOCOL Protocol #X31025 A Phase 1 Evaluation of the Safety and Tolerability of TAK228 in Combination with TAK117 and in Advanced

How to fill out a first-in-human phase i

How to fill out a first-in-human phase i

1. Identify the objective of the Phase I study, focusing on assessing safety and dosage.
2. Develop a detailed study protocol outlining the study design, objectives, and methodology.
3. Obtain regulatory approval from relevant authorities (e.g., FDA, EMA).
4. Recruit a small group of healthy volunteers or patients depending on the therapy being tested.
5. Prepare informed consent documents explaining the risks and procedures to participants.
6. Administer the drug or therapy according to the study protocol.
7. Monitor participants closely for adverse effects and collect data on safety and tolerability.
8. Prepare interim and final reports summarizing the findings and any recommendations for further studies.

Who needs a first-in-human phase i?

1. Pharmaceutical and biotechnology companies developing new drugs or therapies.
2. Investigators and researchers conducting clinical trials to test new treatments.
3. Regulatory agencies assessing the safety of new medical interventions.
4. Patients who may benefit from novel therapies undergoing early evaluation.

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What is a first-in-human phase i?

A first-in-human phase I trial is a clinical study conducted to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug or treatment in human participants for the first time.

Who is required to file a first-in-human phase i?

Typically, pharmaceutical companies, biotechnology firms, or research institutions that intend to initiate clinical trials of new drugs are required to file a first-in-human phase I application.

How to fill out a first-in-human phase i?

To fill out a first-in-human phase I application, sponsors must provide detailed information including the study protocol, investigational product details, informed consent process, safety monitoring plans, and data collection methods for trial participants.

What is the purpose of a first-in-human phase i?

The purpose of a first-in-human phase I trial is to evaluate the safety profile of the drug, determine the maximum tolerated dose, and understand its pharmacological effects in humans.

What information must be reported on a first-in-human phase i?

Information that must be reported includes study objectives, inclusion/exclusion criteria for participants, dosing regimen, monitoring procedures, potential risks, and plans for data analysis.