NCT05701644

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Ensol Bioscience · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-01-02
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2023-01-27
• Last updated: 2024-04-04

Locations

1 site across 1 country: South Korea