Clinical trial NCT05980065: To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ensol Biosciences, Inc.
First posted: 2023-08-07
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety assessment by adverse event monitoring
timeFrame: up to 23 days
measure: Cmax
timeFrame: At day 1
measure: Cmax
timeFrame: At day 15
measure: AUC
timeFrame: At day 1
measure: AUC
timeFrame: At day 15
Secondary outcomes:
measure: Safety-Injection site response evaluation
timeFrame: up to 23 days
measure: Systolic blood pressure
timeFrame: up to 23 days
measure: Diastolic blood pressure
timeFrame: up to 23 days
measure: Pulse rate
timeFrame: up to 23 days
measure: QT interval
timeFrame: up to 23 days
measure: QTc interval
timeFrame: up to 23 days
measure: PR interval
timeFrame: up to 23 days
measure: QRS interval
timeFrame: up to 23 days
Other outcomes:
Locations:
city: SEoul
country: Korea, Republic of
facility: Seoul National University Clinical Trial Center
Study officials:
affiliation: Seoul National University Hospital
name: JAESEONG OH
role: PRINCIPAL_INVESTIGATOR
References: