What is the main focus of Phase I clinical trials?

What is the main focus of Phase I clinical trials?

• A. To investigate long-term effects of a drug
• B. To assess the safety and tolerability of a drug
• C. To evaluate the effectiveness of a treatment in a large population
• D. To identify drug interactions

Answer: (B)

Phase I clinical trials primarily focus on assessing the safety and tolerability of a drug. These trials are the first step in testing a new medication in humans and involve a small group of participants. The main objectives during this phase are to determine the drug's pharmacokinetics (how the drug is processed in the body), establish a safe dosage range, and identify any potential side effects. This phase is crucial because it provides the early data needed to ensure that the drug is safe for further testing in larger populations. While other aspects, such as long-term effects, effectiveness, and drug interactions, may be considered in later phases of trials, Phase I is specifically centered on gathering information on how the body reacts to the drug in terms of safety.

Phase I clinical trials primarily focus on assessing the safety and tolerability of a drug. These trials are the first step in testing a new medication in humans and involve a small group of participants. The main objectives during this phase are to determine the drug's pharmacokinetics (how the drug is processed in the body), establish a safe dosage range, and identify any potential side effects.

This phase is crucial because it provides the early data needed to ensure that the drug is safe for further testing in larger populations. While other aspects, such as long-term effects, effectiveness, and drug interactions, may be considered in later phases of trials, Phase I is specifically centered on gathering information on how the body reacts to the drug in terms of safety.