Intervention Type for ClinicalTrials.gov
A Safety, Tolerability, and Pharmacokinetics Study of AP303 in Healthy Subjects
A Single-center Randomized Double-blind Placebo-controlled Study to Investigate the Safety Tolerability and PK of SAD and MAD of AP303 Following Oral Administration and the Effect of Food on the PK of AP303 in Healthy Subjects
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Safety, Tolerability, Pharmacokinetics, AP303, Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered AP303 will be assessed in healthy adult subjects.
The study will consist of 2 parts: Part A is a single ascending doses (SAD) phase enrolling a total of 4 cohorts of healthy subjects; Part B is a multiple ascending doses (MAD) phase enrolling 3 cohorts of healthy subjects. One cohort of Part A will receive AP303 under both fasted and fed conditions to investigate the effect of food.
Oversight Classifier: oversightHasDmc True
Oversight Classifier: isFdaRegulatedDrug False
Oversight Classifier: isFdaRegulatedDevice False
Single Dose and Food Effect Safety Outcome Measures
Incidence and severity of adverse events (AEs), laboratory, ECG, and vital sign changes
Incidence and severity of AEs, laboratory, ECG, and vital sign changes.
Ae and CLR (if warranted) after single dose
Ae and CLR (if warranted) after multiple dose
Effect of Food on the single dose AUC0-last
Effect of Food on the single dose AUC0-inf
Effect of Food on the single dose Ae and CLR (if warranted)