Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
NCT Number: NCT06736912
This study aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and food effect of IN-114199 in healthy participants
Trial opening soon.
Get Notified19 year–63 year
All sexes
Interventional
Phase 1
Seoul, South Korea
Part A: SAD and FES study
Part B: MAD study
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IN-114199 2.5mg or placebo (1 Tablet, QD)
IN-114199 10mg or placebo (1 Tablet, QD)
IN-114199 10mg or placebo (2 Tablets, QD)
IN-114199 10mg or placebo (4 Tablets, QD)
IN-114199 2.5mg or placebo (2 Tablets, QD)
Time frame: Up to Post Study Visit (Part I SAD: Day 7~Day 9/ Part I SAD, FES: Day 14~ Day 16/ Part II:Day 13~Day 15)
For all adverse events collected during the study, the investigator will evaluate serious adverse events, severity, or drug relationship
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Vital sign results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Time frame: Part I : Up to Day 3/ Part II: Up to Day 9
Physical examination results will be classified as normal, not clinically significant, or clinically significant upon a judgment of the investigator after single/multiple dosing of IN-114199.
Time frame: Part I : Up to Day 3 / Part II: Up to Day 9
The body weight in kilograms of Subjects will be monitored daily from the administration of IN-114199 until their discharge
Time frame: Part I SAD: Up to Day 3 / Part II: Up to Day 9
QT/QTc interval will be recorded and analyzed automatically.
Time frame: Part I:Day 1, Day 3/ Part II: Day 1, Day 3, Day 5, Day 7, Day 9
Clinical laboratory test, the results will be classified as normal, not clinically significant, or clinically significant upon judgment of the investigator after single/multiple dosing of IN-114199
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
Cmax
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
AUClast
Time frame: Part I SAD: Up to Day 3/ Part I SAD, FES: Up to Day 3 / Part II: Up to Day 9
AUEClast
Time frame: Part I SAD: Up to Day 2/ Part I SAD, FES: Up to Day 2 / Part II: Up to Day 8
AUEClast
Contact information is provided by the study sponsor or research team.
Eun Ji Kim
CONTACT
Seung Hee Jung, Ph.D
CONTACT
HK inno.N Corporation
Industry
A Randomized, Double-blind, Placebo-controlled, Single/multiple Dosing, Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety/tolerability, Pharmacokinetic/pharmacodynamic Characteristics and Food Effect After Oral Administration of IN-114199 in Healthy Participants
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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