Study 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
• Intervention / Treatment: Drug: C1K 150mg; Drug: C1K 300mg; Drug: Placebo with the same volume of C1K 300mg; Drug: C1K 600mg; Drug: Placebo with the same volume of C1K 600mg; Drug: C1K 900mg; Drug: Placebo with the same volume of C1K 900mg; Drug: C1K 1200mg; Drug: Placebo with the same volume of C1K 1200mg

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (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: C1K 150mg; Subcutaneous Administration C1K 150mg single or multi dose	Drug: C1K 150mg; Subcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15
Experimental: C1K 300mg or placebo; Subcutaneous Administration C1K 300mg or placebo single or multi dose	Drug: C1K 300mg; Subcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15; Drug: Placebo with the same volume of C1K 300mg; Subcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15
Experimental: C1K 600mg or placebo; Subcutaneous Administration C1K 600mg or placebo single or multi dose	Drug: C1K 600mg; Subcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15; Drug: Placebo with the same volume of C1K 600mg; Subcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15
Experimental: C1K 900mg or placebo; Subcutaneous Administration C1K 900mg or placebo single or multi dose	Drug: C1K 900mg; Subcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15; Drug: Placebo with the same volume of C1K 900mg; Subcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15
Experimental: C1K 1200mg or placebo; Subcutaneous Administration C1K 1200mg or placebo single or multi dose	Drug: C1K 1200mg; Subcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15; Drug: Placebo with the same volume of C1K 1200mg; Subcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability Assessment	Percentage of occurrences observed Adverse Event in each group.	Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Vital Signs	Vital Signs including blood pressure and heart rate changes from baseline.	Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Physical Examination	physical examination changes from baseline.	Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Laboratory Test	laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.	Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram	12-Lead Electrocardiogram(ECG) changes from baseline.	Day -1 to Day 23
Safety and Tolerability Assessment by Response Change of Injection site.	Percentage of occurrences observed response change of injection site.	Day 1 to Day 23
Pharmacokinetic Assessment by Maximum concentration of C1K in plasma	Maximum concentration of C1K in plasma (Cmax)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point	Area under the plasma C1K concentration-time curve from 0 to last(AUClast)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity	Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by The time of peak concentration of C1K	The time of peak concentration(Tmax)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Elimination half-life of C1K	Elimination half-life(t1/2)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Apparent Clearance of C1K	Apparent Clearance(CL/F)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K	Apparent Volume of Distribution After extravascular administration(Vz/F)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Accumulation Ratio of C1K	Accumulation Ratio(Rac)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Minimum concentration of C1K in plasma	Minimum concentration of C1K in plasma(Cmin,ss)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Average concentration of C1K in plasma	Average concentration of C1K in plasma(Cav)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Peak to trough fluctuation ratio	Peak to trough fluctuation ratio(PTF)	Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15

Collaborators and Investigators

• Sponsor: Ensol Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: January 1, 2023

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