NCT05980065

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: 35 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• 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 Subjects

Interventions

Type	Name	Description
DRUG	C1K	Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
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
DRUG	C1K	Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
DRUG	C1K	Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
DRUG	C1K	Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-06-13
• Completion: 2023-10-04
• First posted: 2023-08-07
• Last updated: 2023-12-04

Locations

1 site across 1 country: South Korea