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

NCT05980065 | Completed Phase 1

• 1 other identifier: C1K-101
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (5)

• Safety assessment by adverse event monitoring

  Monitoring of adverse event

  up to 23 days

• Cmax

  Peak Plasma Concentration

  At day 1

• Cmax

  Peak Plasma Concentration

  At day 15

• AUC

  Area under the plasma concentration versus time curve

  At day 1

• AUC

  Area under the plasma concentration versus time curve

  At day 15

Secondary Outcomes (8)

• Safety-Injection site response evaluation

  up to 23 days

• Systolic blood pressure

  up to 23 days

• Diastolic blood pressure

  up to 23 days

• Pulse rate

  up to 23 days

• QT interval

  up to 23 days

Study Arms (5)

Dose level 1

EXPERIMENTAL

C1K 150mg

Drug: C1K

Dose level 2

EXPERIMENTAL

C1K 300mg or placebo

Drug: C1K; Drug: Placebo

Dose level 3

EXPERIMENTAL

C1K 600mg or placebo

Drug: Placebo; Drug: C1K

Dose level 4

EXPERIMENTAL

C1K 900mg or placebo

Drug: Placebo; Drug: C1K

Dose level 5

EXPERIMENTAL

C1K 1200mg or placebo

Drug: Placebo; Drug: C1K

Interventions

C1K DRUG

Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15

Dose level 1

Placebo DRUG

Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15

Dose level 2; Dose level 3; Dose level 4; Dose level 5

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ensol Biosciences, Inc.: collaborator

Study Sites (1)

Seoul National University Clinical Trial Center

Seoul, 03080, South Korea

Location

Study Officials

• JAESEONG OH

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: August 7, 2023
• Study Start: December 20, 2022
• Primary Completion: June 13, 2023
• Study Completion: October 4, 2023
• Last Updated: December 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)