None listed
Conditions
Interventions
Drug : 1) Active drug: assigned 1 group out of C1K 150mg, 300mg, 600mg, 900mg, 1200mg group and abdominal SC injection for maximum three times during the study
2) Placebo: physioligical saline(0.9%
Sponsors
Ensol Biosciences
Eligibility
Sex/Gender
All
Inclusion 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
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) 140 mmHg - diastolic blood pressure 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Monitoring of adverse event 2) Injection site response evaluation 3) vital sign, physical examination, 12-lead ECG and laboratory test (hematology, chemistry, coagulation, urinalysis);Pharmacokinetics test(Single dose:Cmax, AUClast, AUCinf, Tmax, t1/2, CL/F, Vz/F), (Repeated dose: Cmax,ss, AUClast,ss, AUCinf,ss, Tmax,ss, t1/2, CLss/F, Vz,ss/F, Rac, Cmin,ss, Cav,ss, peak to trough fluctuation ratio (PTF)) | — |
Countries
Korea, Republic of
Contacts
Public ContactJiang Xu
Seoul National University Hospital
Outcome results
None listed