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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05701644
• Other study ID #: C1K-101
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2023
• Est. completion date: June 28, 2023

Study information

• Verified date: January 2023
• Source: Ensol Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• C1K 150mg
Subcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15
• C1K 300mg
Subcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15
• Placebo with the same volume of C1K 300mg
Subcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15
• C1K 600mg
Subcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15
• Placebo with the same volume of C1K 600mg
Subcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15
• C1K 900mg
Subcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15
• Placebo with the same volume of C1K 900mg
Subcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15
• C1K 1200mg
Subcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15
• Placebo with the same volume of C1K 1200mg
Subcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ensol Bioscience

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability Assessment	Percentage of occurrences observed Adverse Event in each group.	Day -1 to Day 23
Primary	Safety and Tolerability Assessment by Value Changes in Vital Signs	Vital Signs including blood pressure and heart rate changes from baseline.	Day -1 to Day 23
Primary	Safety and Tolerability Assessment by Value Changes in Physical Examination	physical examination changes from baseline.	Day -1 to Day 23
Primary	Safety and Tolerability Assessment by Value Changes in Laboratory Test	laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.	Day -1 to Day 23
Primary	Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram	12-Lead Electrocardiogram(ECG) changes from baseline.	Day -1 to Day 23
Primary	Safety and Tolerability Assessment by Response Change of Injection site.	Percentage of occurrences observed response change of injection site.	Day 1 to Day 23
Primary	Pharmacokinetic Assessment by Maximum concentration of C1K in plasma	Maximum concentration of C1K in plasma (Cmax)	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
Primary	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)	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
Primary	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)	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
Primary	Pharmacokinetic Assessment by The time of peak concentration of C1K	The time of peak concentration(Tmax)	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
Primary	Pharmacokinetic Assessment by Elimination half-life of C1K	Elimination half-life(t1/2)	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
Primary	Pharmacokinetic Assessment by Apparent Clearance of C1K	Apparent Clearance(CL/F)	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
Primary	Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K	Apparent Volume of Distribution After extravascular administration(Vz/F)	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
Primary	Pharmacokinetic Assessment by Accumulation Ratio of C1K	Accumulation Ratio(Rac)	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
Primary	Pharmacokinetic Assessment by Minimum concentration of C1K in plasma	Minimum concentration of C1K in plasma(Cmin,ss)	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
Primary	Pharmacokinetic Assessment by Average concentration of C1K in plasma	Average concentration of C1K in plasma(Cav)	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
Primary	Pharmacokinetic Assessment by Peak to trough fluctuation ratio	Peak to trough fluctuation ratio(PTF)	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