A Phase I Pharmacokinetics Study for KT07 Capsule

Summary

This is a phase 1 single-center study to assess the pharmacokinetics (PK), safety and tolerability of KT07 capsules in healthy adult subjects. This study consists of 2 parts: Part 1 and Part 2. The primary objectives of Part 1 include selection of suitable PK markers for bioanalysis, development and validation of GLP bioanalytical methods for follow-up PK studies, assessment of PK of potential markers following an oral administration of KT07, and provision of PK sampling strategy for Part 2. The primary objective of Part 2 is to evaluate the PK profile following a single dose and multiple doses in healthy adult subjects.

Timeline

Start

2022-01-07

Primary completion

2022-07-20

Completion

2022-09-06

Drugs

Indications

No indication recorded.