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Completed

NCT Number: NCT05701644

Study To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

C1K 150mg

Drug

Subcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15

C1K 300mg

Drug

Subcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15

Placebo with the same volume of C1K 300mg

Drug

Subcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15

C1K 600mg

Drug

Subcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15

Placebo with the same volume of C1K 600mg

Drug

Subcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15

C1K 900mg

Drug

Subcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15

Placebo with the same volume of C1K 900mg

Drug

Subcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15

C1K 1200mg

Drug

Subcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15

Placebo with the same volume of C1K 1200mg

Drug

Subcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15

Primary outcomes

  1. Safety and Tolerability Assessment

    Time frame: Day -1 to Day 23

    Percentage of occurrences observed Adverse Event in each group.

  2. Safety and Tolerability Assessment by Value Changes in Vital Signs

    Time frame: Day -1 to Day 23

    Vital Signs including blood pressure and heart rate changes from baseline.

  3. Safety and Tolerability Assessment by Value Changes in Physical Examination

    Time frame: Day -1 to Day 23

    physical examination changes from baseline.

  4. Safety and Tolerability Assessment by Value Changes in Laboratory Test

    Time frame: Day -1 to Day 23

    laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.

  5. Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram

    Time frame: Day -1 to Day 23

    12-Lead Electrocardiogram(ECG) changes from baseline.

  6. Safety and Tolerability Assessment by Response Change of Injection site.

    Time frame: Day 1 to Day 23

    Percentage of occurrences observed response change of injection site.

  7. Pharmacokinetic Assessment by Maximum concentration of C1K in plasma

    Time frame: 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

    Maximum concentration of C1K in plasma (Cmax)

  8. Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point

    Time frame: 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

    Area under the plasma C1K concentration-time curve from 0 to last(AUClast)

  9. Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity

    Time frame: 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

    Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)

  10. Pharmacokinetic Assessment by The time of peak concentration of C1K

    Time frame: 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

    The time of peak concentration(Tmax)

  11. Pharmacokinetic Assessment by Elimination half-life of C1K

    Time frame: 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

    Elimination half-life(t1/2)

  12. Pharmacokinetic Assessment by Apparent Clearance of C1K

    Time frame: 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

    Apparent Clearance(CL/F)

  13. Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K

    Time frame: 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

    Apparent Volume of Distribution After extravascular administration(Vz/F)

  14. Pharmacokinetic Assessment by Accumulation Ratio of C1K

    Time frame: 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

    Accumulation Ratio(Rac)

  15. Pharmacokinetic Assessment by Minimum concentration of C1K in plasma

    Time frame: 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

    Minimum concentration of C1K in plasma(Cmin,ss)

  16. Pharmacokinetic Assessment by Average concentration of C1K in plasma

    Time frame: 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

    Average concentration of C1K in plasma(Cav)

  17. Pharmacokinetic Assessment by Peak to trough fluctuation ratio

    Time frame: 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

    Peak to trough fluctuation ratio(PTF)

Sponsors and collaborators

Lead sponsor

Ensol Bioscience

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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