Status:
COMPLETED
To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ensol Biosciences, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
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 pharmacok...
Eligibility Criteria
Inclusion
- Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- 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.
- Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- 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
- A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- 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
- 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
- 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
- Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
- 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
- A subject with a history of drug abuse or positive urine screening test for drug abuse
- 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).
- A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose
- 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
- Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.
- 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
- 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
- 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)
- Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05980065
Start Date
December 20 2022
End Date
October 4 2023
Last Update
December 4 2023
Active Locations (1)
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1
Seoul National University Clinical Trial Center
Seoul, South Korea, 03080