Healthy SubjectsPhase 1NCT05980065
To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
A Phase 1 study testing C1K in people with Healthy Subjects, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- C1K
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2022to 4 Oct 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in the range 18-27 kg/m2.
- Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in the opinion of the investigator, the subject is suitable for the study.
Who cannot join
- A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- A subject who has hypersensitivity to the drugs of the drugs containing the same class, or other drugs, or a history of clinically significant hypersensitivity
- A subject who has ventricular tachycardia, ventricular tachycardia, ventricular flutter or confirmed other ventricular flutter and QTc interval: > 450 ms or the other clinically significant medical findings
- A subject with the following results in the screening test:
- Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
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- Blood CPK > Normal range upper × 1.5
- eGFR (CKD-EPI equation) < 60 mL/min/1.73 m2
- Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
- A subject with the following results in the screening test:
- systolic blood pressure < 80 mmHg or > 140 mmHg
- diastolic blood pressure < 50 mmHg or > 90 mmHg
- A subject with a history of drug abuse or positive urine screening test for drug abuse
- A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug) or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator).
- A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose
- A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
- Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.
- A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
- A male subject who has plan to have a baby or to donate sperm. A female subject who is pregnant or lactating or has plan to lactate within 3 months after administration of IP
- A subject who is intending to become pregnant during this study or with inability to use a medically acceptable contraception method(ex. sterilization operation, intrauterine device etc. for Subject or subject's partner
- ※ medically acceptable contraception method
- Use of intrauterine device which is proven pregnancy failure rates in spouses (or partners).
- Use combined blocking contraceptives (for male or female) and antiseptic drugs
- Subject or partner's operation(vasectomized, bilateral tubal occlusion, hysterectomy)
- Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Clinical Trial Center
Seoul, 03080
About this study
Official title: A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.
- Conditions
- Healthy Subjects
- Being tested
- C1K, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1KDrug
Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
C1KDrug
Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15
PlaceboDrug
Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
C1KDrug
Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
C1KDrug
Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
C1KDrug
Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | C1K 150mg Receives: Drug: C1K |
| Dose level 2 | Experimental | C1K 300mg or placebo Receives: Drug: C1K; Drug: Placebo |
| Dose level 3 | Experimental | C1K 600mg or placebo Receives: Drug: Placebo; Drug: C1K |
| Dose level 4 | Experimental | C1K 900mg or placebo Receives: Drug: Placebo; Drug: C1K |
| Dose level 5 | Experimental | C1K 1200mg or placebo Receives: Drug: Placebo; Drug: C1K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment by adverse event monitoring
Monitoring of adverse event
Measured: up to 23 days
Cmax
Peak Plasma Concentration
Measured: At day 1
Cmax
Peak Plasma Concentration
Measured: At day 15
AUC
Area under the plasma concentration versus time curve
Measured: At day 1
AUC
Area under the plasma concentration versus time curve
Measured: At day 15
Secondary outcomes (8)
Safety-Injection site response evaluation
To evaluate safety
Measured: up to 23 days
Systolic blood pressure
Monitoring of vital signs
Measured: up to 23 days
Diastolic blood pressure
Monitoring of vital signs
Measured: up to 23 days
Pulse rate
Monitoring of vital signs
Measured: up to 23 days
QT interval
Monitoring of 12-lead electrocardiogram
Measured: up to 23 days
QTc interval
Monitoring of 12-lead electrocardiogram
Measured: up to 23 days
PR interval
Monitoring of 12-lead electrocardiogram
Measured: up to 23 days
QRS interval
Monitoring of 12-lead electrocardiogram
Measured: up to 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start20 Dec 2022
- Primary completion13 Jun 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ensol Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- JAESEONG OH, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980065
- Sponsor's protocol ID
- C1K-101
- Status last verified
- Dec 2022
- First submitted
- 19 Apr 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05980065
- Acronym / sponsor ID
- C1K-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ensol Biosciences, Inc.
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 7 Aug 2023 (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.
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: C1KC1K 150mg |
| Dose level 2 | Experimental | Drug: C1K, Drug: PlaceboC1K 300mg or placebo |
| Dose level 3 | Experimental | Drug: Placebo, Drug: C1KC1K 600mg or placebo |
| Dose level 4 | Experimental | Drug: Placebo, Drug: C1KC1K 900mg or placebo |
| Dose level 5 | Experimental | Drug: Placebo, Drug: C1KC1K 1200mg or placebo |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in the range 18-27 kg/m2.
- Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in the opinion of the investigator, the subject is suitable for the study.
Key exclusion criteria (25 listed)
- A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- A subject who has hypersensitivity to the drugs of the drugs containing the same class, or other drugs, or a history of clinically significant hypersensitivity
- A subject who has ventricular tachycardia, ventricular tachycardia, ventricular flutter or confirmed other ventricular flutter and QTc interval: > 450 ms or the other clinically significant medical findings
- A subject with the following results in the screening test:
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 |
|---|---|---|
| C1KSubcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15 | Drug | Dose level 1 |
| C1KSubcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15 | Drug | Dose level 2 |
| PlaceboSubcutaneously administrate placebo at 0 Day 1, Day 8, Day 15 | Drug | Dose level 2, Dose level 3, Dose level 4, Dose level 5 |
| C1KSubcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15 | Drug | Dose level 3 |
| C1KSubcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15 | Drug | Dose level 4 |
| C1KSubcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15 | Drug | Dose level 5 |
Primary outcome
Safety assessment by adverse event monitoring
Time frame: up to 23 days
Monitoring of adverse event
Cmax
Time frame: At day 1
Peak Plasma Concentration
Cmax
Time frame: At day 15
Peak Plasma Concentration
AUC
Time frame: At day 1
Area under the plasma concentration versus time curve
AUC
Time frame: At day 15
Area under the plasma concentration versus time curve
8 secondary outcomes
Safety-Injection site response evaluation
Time frame: up to 23 days
Systolic blood pressure
Time frame: up to 23 days
Diastolic blood pressure
Time frame: up to 23 days
Pulse rate
Time frame: up to 23 days
QT interval
Time frame: up to 23 days
QTc interval
Time frame: up to 23 days
PR interval
Time frame: up to 23 days
QRS interval
Time frame: up to 23 days
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 4 Dec 2023.
- 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.
JAESEONG OH principal investigator
Seoul National University Hospital
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 C1K in people with Healthy Subjects, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 25 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 4 Dec 2023. 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 South Korea. 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. 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?
Safety assessment by adverse event monitoring (time frame: up to 23 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2023.