Diabetic Macular EdemaPhase 1NCT04795037
First-In-Human Study of CU06-1004 Following Single and Multiple Ascending Doses in Healthy Volunteers
A Phase 1 study testing CU06-1004, Single dose and CU06-1004, Multiple doses in people with Diabetic Macular Edema, run by Curacle Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- CU06-1004, Single dose and CU06-1004, Multiple doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 25 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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).
- Food and beverages containing alcohol for 48 hours prior to the first dosing.
- Food and beverages containing grapefruit/Seville orange for 14 days prior to the first dosing.
- Food and beverages containing vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard) and charbroiled meats for 14 days prior to the first dosing.
- Has received COVID-19 vaccine within 30 days of first dosing and until the end of the study.
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.
- Is lactose intolerant (FE cohort only).
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days prior to the first dosing. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to the first dose of study drug in the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- CU06-1004, Single dose, CU06-1004, Multiple doses, Placebo
- Keywords
- DME, Endothelial dysfunction blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU06-1004, Single doseDrug
Also called SAC-1004, CU06, CU06-RE
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
CU06-1004, Multiple dosesDrug
Also called SAC-1004, CU06, CU06-RE
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
PlaceboDrug
Placebo matched to CU06-1004, oral capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of first dose through 7 days after the last dose
Secondary outcomes (10)
Maximum plasma concentration (Cmax)
To assess Cmax of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Time to reach maximum plasma concentration (Tmax)
To assess Tmax of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Area under the concentration-time curve (AUC)
To assess AUC of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Terminal elimination rate constant (Kel)
To assess Kel of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Terminal elimination half-life (t½)
To assess t½ of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Maximum plasma concentration (Cmax) under fed conditions
To assess Cmax of single oral dose under fed conditions
Measured: Day 1 through Day 4 (SAD)
Area under the concentration-time curve (AUC) under fed conditions
To assess AUC of single oral dose under fed conditions
Measured: Day 1 through Day 4 (SAD)
Amount of unchanged drug excreted in the urine collection (Ae)
To assess Ae of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Renal Clearance (CLR)
To assess CLR of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Fraction of drug excreted unchanged in urine (Fe)
To assess Fe of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects
Measured: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start15 Jul 2021
- Primary completion2 Mar 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curacle Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Responsible party
- Sponsor
- Investigators
- Ji-Hye Kang, Ph.D, Study director, Curacle Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795037
- Sponsor's protocol ID
- CU06-1004-DME-01
- Status last verified
- Jul 2022
- First submitted
- 5 Mar 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18446514Schuirmann 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.
PubMed 3450848
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04795037
- Acronym / sponsor ID
- CU06-1004-DME-01
- Conditions
- Diabetic Macular Edema
- Keywords
- DME, Endothelial dysfunction blocker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Curacle Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KCRN Research, LLC
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| CU06-1004 for SAD | Experimental | Drug: CU06-1004, Single dose* 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 |
| Placebo for SAD | Placebo comparator | Drug: Placebo* 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 |
| CU06-1004 for MAD | Experimental | Drug: CU06-1004, Multiple doses* 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 |
| Placebo for MAD | Placebo comparator | Drug: Placebo* 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 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CU06-1004, Single doseAlso: SAC-1004, CU06, CU06-RESingle 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 for SAD |
| CU06-1004, Multiple dosesAlso: SAC-1004, CU06, CU06-REMultiple 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 | CU06-1004 for MAD |
| PlaceboPlacebo matched to CU06-1004, oral capsule | Drug | Placebo for MAD, Placebo for SAD |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: From the date of first dose through 7 days after the last dose
To assess the safety and tolerability of single and multiple ascending oral doses of CU06-1004 in healthy adult subjects.
10 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Time to reach maximum plasma concentration (Tmax)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Area under the concentration-time curve (AUC)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Terminal elimination rate constant (Kel)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Terminal elimination half-life (t½)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Maximum plasma concentration (Cmax) under fed conditions
Time frame: Day 1 through Day 4 (SAD)
Area under the concentration-time curve (AUC) under fed conditions
Time frame: Day 1 through Day 4 (SAD)
Amount of unchanged drug excreted in the urine collection (Ae)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Renal Clearance (CLR)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Fraction of drug excreted unchanged in urine (Fe)
Time frame: Day 1 through Day 4 (SAD), Day 1 through Day 10 (MAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 18446514Maganti 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.
- Background: PubMed 3450848Schuirmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji-Hye Kang, Ph.D study director
Curacle Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CU06-1004, Single dose and CU06-1004, Multiple doses in people with Diabetic Macular Edema, run by Curacle Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: From the date of first dose through 7 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04795037, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.