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

NCT04795037 | Completed Phase 1 FDA Drug

• 1 other identifier: CU06-1004-DME-01
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DME; Endothelial dysfunction blocker

Outcome Measures

Primary Outcomes (1)

• The number and severity of treatment emergent adverse events (TEAEs)

  To assess the safety and tolerability of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects.

  From the date of first dose through 7 days after the last dose

Secondary Outcomes (10)

• Maximum plasma concentration (Cmax)

  Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)

• Time to reach maximum plasma concentration (Tmax)

  Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)

• Area under the concentration-time curve (AUC)

  Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)

• Terminal elimination rate constant (Kel)

  Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)

• Terminal elimination half-life (t½)

  Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)

Study Arms (4)

CU06-1004 for SAD

EXPERIMENTAL

* Fifty-six (56) healthy subjects are planned to be enrolled in 7 cohorts * 6 of out 8 subjects per cohort will be randomized to receive CU06-1004

Drug: CU06-1004, Single dose

Placebo for SAD

PLACEBO COMPARATOR

* Fifty-six (56) healthy subjects are planned to be enrolled in 7 cohorts * 2 of out 8 subjects per cohort will be randomized to receive placebo

Drug: Placebo

CU06-1004 for MAD

EXPERIMENTAL

* Twenty-four (24) healthy subjects are planned to be enrolled in 3 cohorts * 6 of out 8 subjects per cohort will be randomized to receive CU06-1004

Drug: CU06-1004, Multiple doses

Placebo for MAD

PLACEBO COMPARATOR

* Twenty-four (24) healthy subjects are planned to be enrolled in 3 cohorts * 2 of out 8 subjects per cohort will be randomized to receive placebo

Drug: Placebo

Interventions

CU06-1004, Single dose DRUG

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

Also known as: SAC-1004, CU06, CU06-RE

CU06-1004 for SAD

CU06-1004, Multiple doses DRUG

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

Also known as: SAC-1004, CU06, CU06-RE

CU06-1004 for MAD

Placebo DRUG

Placebo matched to CU06-1004, oral capsule

Placebo for MAD; Placebo for SAD

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at screening.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study, based on subject self-reporting.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
• Female must be of non-childbearing potential and must have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after the last dosing.
• (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to the first dosing. A male who has been vasectomized less than 4 months prior to the first dosing must follow the same restrictions as a non-vasectomized male).
• If male, must agree not to donate sperm from the first dosing until 90 days after the last dosing.
• Able to swallow multiple capsules.
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
• Female subjects of childbearing potential.
• Female subjects with a positive pregnancy test at screening or first check-in or who are lactating.
• Positive urine drug or alcohol results at screening or first check-in.
• Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
• Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg, at screening.
• Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
• QTcF interval is \>460 msec (males) or \>470 msec (females) or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening.
• Unable to refrain from or anticipates the use of:
• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements (especially sulforaphane-containing supplement) beginning 14 days prior to the first dosing and throughout the study. After randomization, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.
• Food and beverages containing xanthines/caffeine for 24 hours prior to the first dosing (small amounts of caffeine derived from normal foodstuffs e.g.,250 mL/8 oz./1 cup decaffeinated coffee or other decaffeinated beverage, per day, with the exception of espresso; 45 g/1.5 oz. chocolate bar, per day, would not be considered a deviation to this restriction).

Sponsors & Collaborators

• Curacle Co., Ltd.: lead
• KCRN Research, LLC: collaborator

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Publications (2)

• Maganti L, Panebianco DL, Maes AL. Evaluation of methods for estimating time to steady state with examples from phase 1 studies. AAPS J. 2008;10(1):141-7. doi: 10.1208/s12248-008-9014-y. Epub 2008 Feb 28.

  PMID: 18446514 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

MeSH Terms

Interventions

CU06-1004

Study Officials

• Ji-Hye Kang, Ph.D

  Curacle Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single Ascending Dose(SAD) study with 7 Cohorts including 1 Cohorts for Food effect (FE) assessment with 8 subjects each (6 active and 2 placebo) and A Multiple Ascending Dose(MAD) study with 3 Cohorts with 8 subjects each (6 active and 2 placebo).

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 12, 2021
• Study Start: July 15, 2021
• Primary Completion: March 2, 2022
• Study Completion: June 25, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)