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

NCT05701644 | Completed Phase 1

• 1 other identifier: C1K-101
• Study Type: interventional
• Target: 36
• 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

Outcome Measures

Primary Outcomes (17)

• Safety and Tolerability Assessment

  Percentage of occurrences observed Adverse Event in each group.

  Day -1 to Day 23

• 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

• Safety and Tolerability Assessment by Value Changes in Physical Examination

  physical examination changes from baseline.

  Day -1 to Day 23

• 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

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

  12-Lead Electrocardiogram(ECG) changes from baseline.

  Day -1 to Day 23

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

  Percentage of occurrences observed response change of injection site.

  Day 1 to Day 23

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

C1K 150mg

EXPERIMENTAL

Subcutaneous Administration C1K 150mg single or multi dose

Drug: C1K 150mg

C1K 300mg or placebo

EXPERIMENTAL

Subcutaneous Administration C1K 300mg or placebo single or multi dose

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

C1K 600mg or placebo

EXPERIMENTAL

Subcutaneous Administration C1K 600mg or placebo single or multi dose

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

C1K 900mg or placebo

EXPERIMENTAL

Subcutaneous Administration C1K 900mg or placebo single or multi dose

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

C1K 1200mg or placebo

EXPERIMENTAL

Subcutaneous Administration C1K 1200mg or placebo single or multi dose

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

Interventions

C1K 150mg DRUG

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

C1K 150mg

C1K 300mg DRUG

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

C1K 300mg or placebo

Placebo with the same volume of C1K 300mg DRUG

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

C1K 300mg or placebo

C1K 600mg DRUG

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

C1K 600mg or placebo

Placebo with the same volume of C1K 600mg DRUG

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

C1K 600mg or placebo

C1K 900mg DRUG

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

C1K 900mg or placebo

Placebo with the same volume of C1K 900mg DRUG

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

C1K 900mg or placebo

C1K 1200mg DRUG

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

C1K 1200mg or placebo

Placebo with the same volume of C1K 1200mg DRUG

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

C1K 1200mg or placebo

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

• Ensol Bioscience: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 27, 2023
• Study Start: January 2, 2023
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: April 4, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)