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

• Sponsor: Ensol Bioscience (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05701644
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	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	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 2, 2023
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety and Tolerability Assessment [Day -1 to Day 23]

   Percentage of occurrences observed Adverse Event in each group.

2. Safety and Tolerability Assessment by Value Changes in Vital Signs [Day -1 to Day 23]

   Vital Signs including blood pressure and heart rate changes from baseline.

3. Safety and Tolerability Assessment by Value Changes in Physical Examination [Day -1 to Day 23]

   physical examination changes from baseline.

4. Safety and Tolerability Assessment by Value Changes in Laboratory Test [Day -1 to Day 23]

   laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.

5. Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram [Day -1 to Day 23]

   12-Lead Electrocardiogram(ECG) changes from baseline.

6. Safety and Tolerability Assessment by Response Change of Injection site. [Day 1 to Day 23]

   Percentage of occurrences observed response change of injection site.

7. Pharmacokinetic Assessment by Maximum concentration of C1K in plasma [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]

   Maximum concentration of C1K in plasma (Cmax)

8. Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point [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]

   Area under the plasma C1K concentration-time curve from 0 to last(AUClast)

9. Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity [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]

   Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)

10. Pharmacokinetic Assessment by The time of peak concentration of C1K [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]

    The time of peak concentration(Tmax)

11. Pharmacokinetic Assessment by Elimination half-life of C1K [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]

    Elimination half-life(t1/2)

12. Pharmacokinetic Assessment by Apparent Clearance of C1K [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]

    Apparent Clearance(CL/F)

13. Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K [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]

    Apparent Volume of Distribution After extravascular administration(Vz/F)

14. Pharmacokinetic Assessment by Accumulation Ratio of C1K [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]

    Accumulation Ratio(Rac)

15. Pharmacokinetic Assessment by Minimum concentration of C1K in plasma [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]

    Minimum concentration of C1K in plasma(Cmin,ss)

16. Pharmacokinetic Assessment by Average concentration of C1K in plasma [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]

    Average concentration of C1K in plasma(Cav)

17. Pharmacokinetic Assessment by Peak to trough fluctuation ratio [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]

    Peak to trough fluctuation ratio(PTF)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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

2. 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

1. A subject with a history of drug abuse or positive urine screening test for drug abuse

2. 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).

3. A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose

4. 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

5. Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.

6. 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

7. 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

8. 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)

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Ensol Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ensol Bioscience
• ClinicalTrials.gov Identifier: NCT05701644
• Other Study ID Numbers: C1K-101
• First Posted: Jan 27, 2023
• Last Update Posted: Jan 27, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 27, 2023