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

NCT05701644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-04-04

No results posted yet for this study

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

Interventions

DRUG

C1K 150mg

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

DRUG

C1K 300mg

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

DRUG

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

DRUG

C1K 600mg

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

DRUG

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

DRUG

C1K 900mg

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

DRUG

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

DRUG

C1K 1200mg

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

DRUG

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

Sponsors & Collaborators

  • Ensol Bioscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2023-06-28
Completion
2023-06-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701644 on ClinicalTrials.gov