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

NCT ID: NCT05980065

Last Updated: 2023-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2023-10-04

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dose level 1

C1K 150mg

Group Type: EXPERIMENTAL

C1K

Intervention Type: DRUG

Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15

Dose level 2

C1K 300mg or placebo

Group Type: EXPERIMENTAL

C1K

Intervention Type: DRUG

Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15

Placebo

Intervention Type: DRUG

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

Dose level 3

C1K 600mg or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

C1K

Intervention Type: DRUG

Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15

Dose level 4

C1K 900mg or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

C1K

Intervention Type: DRUG

Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15

Dose level 5

C1K 1200mg or placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

C1K

Intervention Type: DRUG

Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Interventions

C1K

Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

C1K

Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

Placebo

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

C1K

Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

C1K

Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

C1K

Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ensol Biosciences, Inc.

UNKNOWN

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JAESEONG OH

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

C1K-101

Identifier Type: -

Identifier Source: org_study_id