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 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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: C1K; Drug: C1K; Drug: C1K; Drug: C1K; Drug: C1K; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • SEoul, Korea, Republic of, 03080
    • Seoul National University Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
2. 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.
3. Sufficient ability to understand the study after being informed about the study and provide written informed consent.
4. 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:

1. A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
2. A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
3. 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
4. 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

5. 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
6. Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)

7. 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
8. A subject with a history of drug abuse or positive urine screening test for drug abuse
9. 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).
10. A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose
11. 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
12. Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.
13. 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
14. 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

15. 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)
16. Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose level 1; C1K 150mg	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15
Experimental: Dose level 2; C1K 300mg or placebo	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15; Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Experimental: Dose level 3; C1K 600mg or placebo	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15; Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Experimental: Dose level 4; C1K 900mg or placebo	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15; Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Experimental: Dose level 5; C1K 1200mg or placebo	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15; Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment by adverse event monitoring	Monitoring of adverse event	up to 23 days
Cmax	Peak Plasma Concentration	At day 1
Cmax	Peak Plasma Concentration	At day 15
AUC	Area under the plasma concentration versus time curve	At day 1
AUC	Area under the plasma concentration versus time curve	At day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety-Injection site response evaluation	To evaluate safety	up to 23 days
Systolic blood pressure	Monitoring of vital signs	up to 23 days
Diastolic blood pressure	Monitoring of vital signs	up to 23 days
Pulse rate	Monitoring of vital signs	up to 23 days
QT interval	Monitoring of 12-lead electrocardiogram	up to 23 days
QTc interval	Monitoring of 12-lead electrocardiogram	up to 23 days
PR interval	Monitoring of 12-lead electrocardiogram	up to 23 days
QRS interval	Monitoring of 12-lead electrocardiogram	up to 23 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ensol Biosciences, Inc.
• Investigators: Principal Investigator: JAESEONG OH, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: C1K-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No