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

Healthy Subjects 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: NCT05980065
• Other study ID #: C1K-101
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2022
• Est. completion date: October 4, 2023

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• 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: 35
• Est. completion date: October 4, 2023
• Est. primary completion date: June 13, 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 Subjects

Intervention

Drug:
• C1K
Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
• C1K
Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15
• Placebo
Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
• C1K
Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
• C1K
Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
• C1K
Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Clinical Trial Center	SEoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ensol Biosciences, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment by adverse event monitoring	Monitoring of adverse event	up to 23 days
Primary	Cmax	Peak Plasma Concentration	At day 1
Primary	Cmax	Peak Plasma Concentration	At day 15
Primary	AUC	Area under the plasma concentration versus time curve	At day 1
Primary	AUC	Area under the plasma concentration versus time curve	At day 15
Secondary	Safety-Injection site response evaluation	To evaluate safety	up to 23 days
Secondary	Systolic blood pressure	Monitoring of vital signs	up to 23 days
Secondary	Diastolic blood pressure	Monitoring of vital signs	up to 23 days
Secondary	Pulse rate	Monitoring of vital signs	up to 23 days
Secondary	QT interval	Monitoring of 12-lead electrocardiogram	up to 23 days
Secondary	QTc interval	Monitoring of 12-lead electrocardiogram	up to 23 days
Secondary	PR interval	Monitoring of 12-lead electrocardiogram	up to 23 days
Secondary	QRS interval	Monitoring of 12-lead electrocardiogram	up to 23 days