A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part A: Fasting Single ascending dose (SAD). |
Drug: NXC736
Oral administration
Drug: Placebo
Oral administration
|
Experimental: Part A: Fed Single ascending dose (SAD). |
Drug: NXC736
Oral administration
Drug: Placebo
Oral administration
|
Experimental: Part B: Fasting Multiple Ascending Dose (MAD) |
Drug: NXC736
Oral administration
Drug: Placebo
Oral administration
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adult males aged between 19 and 55 at screening
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Those whose weight is between 55 and 90 kg and BMI is between 18.0 and 30.0
-
Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
-
Signed informed consent form
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
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Systolic blood pressure below 90 mmHg or above 140 mmHg
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diastolic blood pressure less than 50 mmHg or greater than 90 mmHg
-
Pulse rate less than 50 beats per minute or more than 90 beats per minute
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A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:
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PR > 210 msec
-
QRS complex > 120 msec
-
QTcB > 450 msec
-
A person who exhibits any of the following results in a clinical laboratory examination at the time of screening ;
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glomerular filtration rate (eGFR, CKD-EPI) < 60 mL/min/1.73 m2
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WBC count < 3500/μL
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Absolute neutrophil count (ANC) < 1500/μL
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AST/ALT > 1.5 X ULN
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- NEXTGEN Bioscience
Investigators
- Principal Investigator: Seungwhan Lee, Seoul National University College of Medicine and Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NXC736-001