Clinical trial NCT05701644: Study 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
Lead sponsor: Ensol Bioscience
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 36
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 and Tolerability Assessment
timeFrame: Day -1 to Day 23
measure: Safety and Tolerability Assessment by Value Changes in Vital Signs
timeFrame: Day -1 to Day 23
measure: Safety and Tolerability Assessment by Value Changes in Physical Examination
timeFrame: Day -1 to Day 23
measure: Safety and Tolerability Assessment by Value Changes in Laboratory Test
timeFrame: Day -1 to Day 23
measure: Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram
timeFrame: Day -1 to Day 23
measure: Safety and Tolerability Assessment by Response Change of Injection site.
timeFrame: Day 1 to Day 23
measure: Pharmacokinetic Assessment by Maximum concentration of C1K in plasma
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by The time of peak concentration of C1K
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Elimination half-life of C1K
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Apparent Clearance of C1K
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Accumulation Ratio of C1K
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Minimum concentration of C1K in plasma
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Average concentration of C1K in plasma
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
measure: Pharmacokinetic Assessment by Peak to trough fluctuation ratio
timeFrame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: