NCT05109663

A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects

A Single-Centre, Single-Administration, Dose-Escalation Study and A Single-Centre, Randomized, Open-Label, Two-cycle Crossover Food Effect Study of SKLB1028 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored the effect of food on the PK of SKLB1028.

Detailed description

The study was divided into 2 parts. Part 1(Dose Escalation) included 2 cohorts (Cohort 1 and Cohort 2) and subjects received a single oral dose of SKLB1028 50 or 100 mg on Day 1. In Part 2 (Food Effect) included 2 cohorts (Cohort A and Cohort B), subjects received a single oral dose of SKLB1028 150 mg in a fasting and a fed state, with a 10-day washout period between the 2 doses.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SKLB1028	SKLB1028, capsule, oral

Timeline

• Start date: 2021-04-14
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-11-05
• Last updated: 2021-11-17

Locations

1 site across 1 country: China