NCT04056130

A Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects

A Phase I Randomized Double-blind Placebo-controlled Study of Single and Multiple Ascending Doses of KBL697 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: KoBioLabs · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is designed to investigate the safety and tolerability of KBL697 in healthy volunteers. KBL697 has been developed as a potential new treatment for atopic dermatitis (AD).

Detailed description

This is a randomized double-blind, placebo-controlled, single centre Phase I study. Thirty-six (36) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows: * Part A (Single Ascending Dose (SAD) in healthy subjects) * Part B (Multiple Ascending Doses (MAD) in healthy subjects)

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	KBL697	Part A: 1 day 460mg/day of KBL697 or placebo Route of Administration: Oral
DRUG	KBL697	Part A: 1 day 4,600mg/day of KBL697 Route of Administration: Oral
DRUG	KBL697	Part B: 14 days Cohort MAD1: 460mg/day of KBL697 Route of Administration: Oral
DRUG	KBL697	Part B: 14 days Cohort MAD2: 4,600mg/day of KBL697 Route of Administration: Oral

Timeline

• Start date: 2019-10-04
• Primary completion: 2019-12-23
• Completion: 2020-01-07
• First posted: 2019-08-14
• Last updated: 2021-09-08

Locations

1 site across 1 country: Australia