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

Not Applicable

• Conditions: Not Applicable

• Registration Number: KCT0008074
• Lead Sponsor: Ensol Biosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: Interventional Study
• Study Design: Not specified