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

NCT04795037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-07-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • KCRN Research, LLC

    collaborator INDUSTRY

  • Curacle Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ji-Hye Kang, Ph.D · Curacle Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2022-03-02
Completion
2022-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04795037 on ClinicalTrials.gov