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CompletedNCT05701644Updated Apr 4, 2024

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

A Phase 1 interventional study of C1K 150mg and C1K 300mg in Healthy, sponsored by Ensol Bioscience. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Ensol Bioscience · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Ensol Bioscience is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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) \< 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    C1K 150mg

    Subcutaneous Administration C1K 150mg single or multi dose

    Drug: C1K 150mg

  • Experimental
    C1K 300mg or placebo

    Subcutaneous Administration C1K 300mg or placebo single or multi dose

    Drug: C1K 300mg · Drug: Placebo with the same volume of C1K 300mg

  • Experimental
    C1K 600mg or placebo

    Subcutaneous Administration C1K 600mg or placebo single or multi dose

    Drug: C1K 600mg · Drug: Placebo with the same volume of C1K 600mg

  • Experimental
    C1K 900mg or placebo

    Subcutaneous Administration C1K 900mg or placebo single or multi dose

    Drug: C1K 900mg · Drug: Placebo with the same volume of C1K 900mg

  • Experimental
    C1K 1200mg or placebo

    Subcutaneous Administration C1K 1200mg or placebo single or multi dose

    Drug: C1K 1200mg · Drug: Placebo with the same volume of C1K 1200mg

Interventions

  • DrugC1K 150mg

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

  • DrugC1K 300mg

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

  • DrugPlacebo with the same volume of C1K 300mg

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

  • DrugC1K 600mg

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

  • DrugPlacebo with the same volume of C1K 600mg

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

  • DrugC1K 900mg

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

  • DrugPlacebo with the same volume of C1K 900mg

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

  • DrugC1K 1200mg

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

  • DrugPlacebo with the same volume of C1K 1200mg

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

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability Assessment

    Percentage of occurrences observed Adverse Event in each group.

    Time frame: Day -1 to Day 23

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

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

    Time frame: Day -1 to Day 23

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

    physical examination changes from baseline.

    Time frame: Day -1 to Day 23

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

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

    Time frame: Day -1 to Day 23

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

    12-Lead Electrocardiogram(ECG) changes from baseline.

    Time frame: Day -1 to Day 23

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

    Percentage of occurrences observed response change of injection site.

    Time frame: Day 1 to Day 23

  7. Pharmacokinetic Assessment by Maximum concentration of C1K in plasma

    Maximum concentration of C1K in plasma (Cmax)

    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

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

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

    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

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

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

    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

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

    The time of peak concentration(Tmax)

    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

  11. Pharmacokinetic Assessment by Elimination half-life of C1K

    Elimination half-life(t1/2)

    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

  12. Pharmacokinetic Assessment by Apparent Clearance of C1K

    Apparent Clearance(CL/F)

    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

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

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

    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

  14. Pharmacokinetic Assessment by Accumulation Ratio of C1K

    Accumulation Ratio(Rac)

    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

  15. Pharmacokinetic Assessment by Minimum concentration of C1K in plasma

    Minimum concentration of C1K in plasma(Cmin,ss)

    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

  16. Pharmacokinetic Assessment by Average concentration of C1K in plasma

    Average concentration of C1K in plasma(Cav)

    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

  17. Pharmacokinetic Assessment by Peak to trough fluctuation ratio

    Peak to trough fluctuation ratio(PTF)

    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

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05701644
Lead sponsor
Ensol Bioscience
Responsible party
Sponsor
First posted
Jan 27, 2023
Start date
Jan 2, 2023
Primary completion
Jun 28, 2023
Completion
Jun 28, 2023
Last update
Apr 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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