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This is a randomized, double-blind, placebo- controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Fasting | Experimental | Single ascending dose (SAD). |
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| Part A: Fed | Experimental | Single ascending dose (SAD). |
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| Part B: Fasting | Experimental | Multiple Ascending Dose (MAD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXC736 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Day 49 | |
| Number of Participants with Serious Adverse Events (SAEs) | Day 49 | |
| Number of Participants with Vital Sign Abnormalities | Day 49 | |
| Number of Participants with Electrocardiogram (ECG) Abnormalities | Day 49 | |
| Number of Participants with Clinical Laboratory Abnormalities | Day 49 |
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Inclusion Criteria:
Exclusion Criteria:
Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
Those who have gastrointestinal diseases or past history of gastrointestinal diseases that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
A person who shows any of the following results in vital signs at the time of screening
A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:
A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;
Those who have a history of tuberculosis infection or who have confirmed positive tuberculosis infection as a result of the Quantiferon TB-Gold test and Chest X-ray performed at the screening test
Persons with acute infectious diseases including herpes virus infection, herpes simplex, and herpes zoster
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Seungwhan Lee | Seoul National University College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Placebo | Drug | Oral administration |
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