MedTrace Logo

A Phase I Pharmacokinetics Study for KT07 Capsule

NCT05223660 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-10-17

No results posted yet for this study

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.

Conditions

  • Healthy Adult Subjects
  • Pharmacokinetics
  • Safety and Tolerability

Interventions

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

Sponsors & Collaborators

  • Yiling Pharmaceutical Inc.

    lead INDUSTRY

Principal Investigators

  • Nan Zhang, PhD · Yiling Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-07-20
Completion
2022-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223660 on ClinicalTrials.gov