Seoul National University Clinical Trial Center
Seoul, 03080, South Korea
NCT Number: NCT05980065
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.
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Notify Me19 year–45 year
All sexes
Interventional
Phase 1
Seoul, 03080, South Korea
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
※ medically acceptable contraception method
Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
Time frame: up to 23 days
Monitoring of adverse event
Time frame: At day 1
Peak Plasma Concentration
Time frame: At day 15
Peak Plasma Concentration
Time frame: At day 1
Area under the plasma concentration versus time curve
Time frame: At day 15
Area under the plasma concentration versus time curve
Time frame: up to 23 days
To evaluate safety
Time frame: up to 23 days
Monitoring of vital signs
Time frame: up to 23 days
Monitoring of vital signs
Time frame: up to 23 days
Monitoring of vital signs
Time frame: up to 23 days
Monitoring of 12-lead electrocardiogram
Time frame: up to 23 days
Monitoring of 12-lead electrocardiogram
Time frame: up to 23 days
Monitoring of 12-lead electrocardiogram
Time frame: up to 23 days
Monitoring of 12-lead electrocardiogram
Seoul National University Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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