Phase 1 (Safety and Dosage)

Phase 1 clinical trials are the first stage of human testing in the drug development process. Often referred to as first-in-human (FIH) studies, they focus primarily on assessing a drug’s safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).
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Both Phase 0 and Phase 1 trials are part of early-phase clinical research, but they serve distinct purposes in drug development. Understanding their differences is critical for planning development strategies, regulatory submissions, and timelines. This article compares the two phases side-by-side to clarify how they fit into the larger clinical trial landscape.
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The protocol is the cornerstone of every clinical trial. In Phase 1 studies—often first-in-human (FIH)—it becomes even more critical due to the exploratory nature, safety risks, and regulatory scrutiny. A well-designed protocol ensures scientific validity, subject safety, operational clarity, and regulatory approval. This tutorial guides you through the essential components and best practices for designing a robust Phase 1 clinical trial protocol.
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Before a Phase 1 clinical trial can begin, sponsors must receive regulatory authorization and ethics approval. The requirements vary by country, but the fundamental goal is the same: to ensure that human participants are protected and that the study is scientifically justified. This guide outlines the submission pathways for key global regions, focusing on the IND (Investigational New Drug) in the U.S., CTA (Clinical Trial Application) in Europe, and CDSCO/Ethics pathways in India.
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Early-phase clinical trials—especially Phase 1 studies—require specialized environments for participant safety, data integrity, and regulatory compliance. Choosing the right site is a critical success factor. From facility readiness to investigator experience, this tutorial explores how to select, prepare, and equip clinical sites for conducting high-quality early-phase trials.
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In first-in-human (FIH) trials, selecting the initial dose is one of the most important and scrutinized decisions. Too high, and you risk harm to participants. Too low, and the data may be non-informative. Regulatory authorities require this decision to be grounded in scientific rationale and supported by preclinical data. This tutorial explores the most commonly used approaches to determine the starting dose: MABEL (Minimum Anticipated Biological Effect Level), NOAEL (No Observed Adverse Effect Level), and BSA (Body Surface Area) scaling.
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In Phase 1 clinical trials, dose escalation is a critical step in determining the maximum tolerated dose (MTD) or identifying a biologically effective dose. The design you choose directly influences patient safety, study duration, statistical rigor, and regulatory acceptance. This tutorial breaks down the most commonly used escalation methods: 3+3 design, Bayesian Optimal Interval (BOIN), modified Toxicity Probability Interval (mTPI), and Continual Reassessment Method (CRM).
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Sentinel dosing is a critical risk mitigation strategy in first-in-human (FIH) clinical trials. It involves administering the investigational product (IP) to one or two participants before exposing additional volunteers to the same dose. This cautious approach allows early detection of serious or unexpected adverse events (AEs) in a controlled setting. In this tutorial, we’ll explore the purpose, implementation, regulatory guidance, and best practices for sentinel dosing in Phase 1 studies.
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Adverse event (AE) monitoring is at the heart of Phase 1 clinical trials, where the primary objective is to establish the safety and tolerability of a new investigational product (IP). Because participants are often exposed to a drug for the first time in humans, detecting, assessing, and reporting AEs accurately is critical to protect subjects and comply with global regulatory standards.
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