NCT04795037

First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CU06-1004 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Curacle Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is the first-in-human study of CU06-1004. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	CU06-1004, Single dose	Single dose of CU06-1004, 7 dose levels, oral capsule : 6 Cohorts (100mg, 300mg, 600mg, 900mg, 1200mg, 300mg bid) + 1 Cohort (Food effect)＊ ＊Cohort S7(TBD mg) will receive a single oral dose of CU06-1004 or placebo under fed conditions. When administered under fed conditions, CU06-1004 or placebo will be administered following a high-fat/high-calorie breakfast. Cohort S7 will be conducted following completion of Cohort S5
DRUG	CU06-1004, Multiple doses	Multiple doses of CU06-1004, 7 days, 3 dose levels＊, oral capsule ＊The dose levels, regimen (i.e., schedule), and conditions (i.e., fasted versus fed conditions) will be determined based on the safety, tolerability, and plasma PK data from SAD
DRUG	Placebo	Placebo matched to CU06-1004, oral capsule

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-03-02
• Completion: 2022-06-25
• First posted: 2021-03-12
• Last updated: 2022-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study