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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05980065
• Collaborator: Ensol Biosciences, Inc. (Other)
• Enrollment: 35
• Location: 1
• Arms: 5
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: C1K; Drug: C1K; Drug: Placebo; Drug: C1K; Drug: C1K; Drug: C1K	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 20, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose level 1 C1K 150mg	Drug: C1K; Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
Experimental: Dose level 2 C1K 300mg or placebo	Drug: C1K; Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15; Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Experimental: Dose level 3 C1K 600mg or placebo	Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
Experimental: Dose level 4 C1K 900mg or placebo	Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
Experimental: Dose level 5 C1K 1200mg or placebo	Drug: Placebo; Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15; Drug: C1K; Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Outcome Measures

Primary Outcome Measures

1. Safety assessment by adverse event monitoring [up to 23 days]

   Monitoring of adverse event

2. Cmax [At day 1]

   Peak Plasma Concentration

3. Cmax [At day 15]

   Peak Plasma Concentration

4. AUC [At day 1]

   Area under the plasma concentration versus time curve

5. AUC [At day 15]

   Area under the plasma concentration versus time curve

Secondary Outcome Measures

1. Safety-Injection site response evaluation [up to 23 days]

   To evaluate safety

2. Systolic blood pressure [up to 23 days]

   Monitoring of vital signs

3. Diastolic blood pressure [up to 23 days]

   Monitoring of vital signs

4. Pulse rate [up to 23 days]

   Monitoring of vital signs

5. QT interval [up to 23 days]

   Monitoring of 12-lead electrocardiogram

6. QTc interval [up to 23 days]

   Monitoring of 12-lead electrocardiogram

7. PR interval [up to 23 days]

   Monitoring of 12-lead electrocardiogram

8. QRS interval [up to 23 days]

   Monitoring of 12-lead electrocardiogram

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: 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:

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

1. Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)

2. 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

1. A subject with a history of drug abuse or positive urine screening test for drug abuse

2. 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).

3. A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose

4. 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

5. Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.

6. 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

7. 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

8. 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)

1. Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Clinical Trial Center	SEoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital
• Ensol Biosciences, Inc.

Investigators

• Principal Investigator: JAESEONG OH, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05980065
• Other Study ID Numbers: C1K-101
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 7, 2023