search
Back to results

To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects

Primary Purpose

Healthy Subjects

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
C1K
C1K
Placebo
C1K
C1K
C1K
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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

Sites / Locations

  • Seoul National University Clinical Trial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose level 1

Dose level 2

Dose level 3

Dose level 4

Dose level 5

Arm Description

C1K 150mg

C1K 300mg or placebo

C1K 600mg or placebo

C1K 900mg or placebo

C1K 1200mg or placebo

Outcomes

Primary Outcome Measures

Safety assessment by adverse event monitoring
Monitoring of adverse event
Cmax
Peak Plasma Concentration
Cmax
Peak Plasma Concentration
AUC
Area under the plasma concentration versus time curve
AUC
Area under the plasma concentration versus time curve

Secondary Outcome Measures

Safety-Injection site response evaluation
To evaluate safety
Systolic blood pressure
Monitoring of vital signs
Diastolic blood pressure
Monitoring of vital signs
Pulse rate
Monitoring of vital signs
QT interval
Monitoring of 12-lead electrocardiogram
QTc interval
Monitoring of 12-lead electrocardiogram
PR interval
Monitoring of 12-lead electrocardiogram
QRS interval
Monitoring of 12-lead electrocardiogram

Full Information

First Posted
April 19, 2023
Last Updated
August 3, 2023
Sponsor
Seoul National University Hospital
Collaborators
Ensol Biosciences, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05980065
Brief Title
To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ensol Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose level 1
Arm Type
Experimental
Arm Description
C1K 150mg
Arm Title
Dose level 2
Arm Type
Experimental
Arm Description
C1K 300mg or placebo
Arm Title
Dose level 3
Arm Type
Experimental
Arm Description
C1K 600mg or placebo
Arm Title
Dose level 4
Arm Type
Experimental
Arm Description
C1K 900mg or placebo
Arm Title
Dose level 5
Arm Type
Experimental
Arm Description
C1K 1200mg or placebo
Intervention Type
Drug
Intervention Name(s)
C1K
Intervention Description
Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
Intervention Type
Drug
Intervention Name(s)
C1K
Intervention Description
Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Intervention Type
Drug
Intervention Name(s)
C1K
Intervention Description
Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
Intervention Type
Drug
Intervention Name(s)
C1K
Intervention Description
Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
Intervention Type
Drug
Intervention Name(s)
C1K
Intervention Description
Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15
Primary Outcome Measure Information:
Title
Safety assessment by adverse event monitoring
Description
Monitoring of adverse event
Time Frame
up to 23 days
Title
Cmax
Description
Peak Plasma Concentration
Time Frame
At day 1
Title
Cmax
Description
Peak Plasma Concentration
Time Frame
At day 15
Title
AUC
Description
Area under the plasma concentration versus time curve
Time Frame
At day 1
Title
AUC
Description
Area under the plasma concentration versus time curve
Time Frame
At day 15
Secondary Outcome Measure Information:
Title
Safety-Injection site response evaluation
Description
To evaluate safety
Time Frame
up to 23 days
Title
Systolic blood pressure
Description
Monitoring of vital signs
Time Frame
up to 23 days
Title
Diastolic blood pressure
Description
Monitoring of vital signs
Time Frame
up to 23 days
Title
Pulse rate
Description
Monitoring of vital signs
Time Frame
up to 23 days
Title
QT interval
Description
Monitoring of 12-lead electrocardiogram
Time Frame
up to 23 days
Title
QTc interval
Description
Monitoring of 12-lead electrocardiogram
Time Frame
up to 23 days
Title
PR interval
Description
Monitoring of 12-lead electrocardiogram
Time Frame
up to 23 days
Title
QRS interval
Description
Monitoring of 12-lead electrocardiogram
Time Frame
up to 23 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seoul National University Clinical Trial Center
Phone
82220721681
Email
simjungin@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAESEONG OH
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Clinical Trial Center
City
SEoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seoul National University Clinical Trial Center
Email
simjungin@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects

We'll reach out to this number within 24 hrs