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

Ensol Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo with the same volume of C1K 300mg; Drug: C1K 1200mg; Drug: Placebo with the same volume of C1K 900mg; Drug: Placebo with the same volume of C1K 1200mg; Drug: C1K 900mg; Drug: C1K 150mg; Drug: C1K 600mg; Drug: C1K 300mg; Drug: Placebo with the same volume of C1K 600mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05701644

C1K-101

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 5 patient groups

C1K 150mg

Experimental group

Description:

Subcutaneous Administration C1K 150mg single or multi dose

Treatment:

Drug: C1K 150mg

C1K 300mg or placebo

Experimental group

Description:

Subcutaneous Administration C1K 300mg or placebo single or multi dose

Treatment:

Drug: Placebo with the same volume of C1K 300mg

Drug: C1K 300mg

C1K 600mg or placebo

Experimental group

Description:

Subcutaneous Administration C1K 600mg or placebo single or multi dose

Treatment:

Drug: Placebo with the same volume of C1K 600mg

Drug: C1K 600mg

C1K 900mg or placebo

Experimental group

Description:

Subcutaneous Administration C1K 900mg or placebo single or multi dose

Treatment:

Drug: Placebo with the same volume of C1K 900mg

Drug: C1K 900mg

C1K 1200mg or placebo

Experimental group

Description:

Subcutaneous Administration C1K 1200mg or placebo single or multi dose

Treatment:

Drug: Placebo with the same volume of C1K 1200mg

Drug: C1K 1200mg