Overview

A Phase I Pharmacokinetics Study for KT07 Capsule

Status:
Recruiting
Trial end date:
2022-09-15
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Yiling Pharmaceutical Inc.