NCT05223660

A Phase I Pharmacokinetics Study for KT07 Capsule

A Phase 1 Single-Center Study to Assess Pharmacokinetics, Safety and Tolerability of KT07 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Yiling Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a 2-part PK study. Each Part consists of 3 phases: a 2-week screening phase, drug administration and PK sampling phase, then a safety follow-up visit at Day 7 after the last dose. Subjects enter screening at Visit 1. Part 1: Pilot single-dose PK Study Part 1 is an open-label study. Six (6) eligible male adult healthy volunteers aged between 18 to 65 years will receive a single oral dose of KT07 capsules on Day 1. Part 2: Single and multiple-dose PK Study A total of 20 healthy subjects will participate in this part of the study, which consists of 2 cohorts with 10 subjects each. Subjects will receive either active treatment or placebo treatment in each cohort in a double-blind manner to evaluate PK and safety of KT07.

Conditions

• Healthy Adult Subjects
• Pharmacokinetics
• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	Low dose KT07	A single dose of 4 capsules, followed by multiple doses on Days 8-12
DRUG	High dose KT07	A single dose of 6 capsules, followed by multiple doses on Days 8-12
DRUG	Low dose Placebo	A single dose of 4 capsules, followed by multiple doses on Days 8-12
DRUG	High dose Placebo	A single dose of 6 capsules, followed by multiple doses on Days 8-12

Timeline

• Start date: 2022-01-07
• Primary completion: 2022-07-20
• Completion: 2022-09-06
• First posted: 2022-02-04
• Last updated: 2022-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study