A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants

Sponsor
NEXTGEN Bioscience (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05079425
Collaborator
(none)
88
1
3
9.7
9.1

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

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect After the Oral Administration of NXC736 in Healthy Male Subjects
Actual Study Start Date :
Sep 10, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

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

  1. Number of Participants with Adverse Events (AEs) [Day 49]

  2. Number of Participants with Serious Adverse Events (SAEs) [Day 49]

  3. Number of Participants with Vital Sign Abnormalities [Day 49]

  4. Number of Participants with Electrocardiogram (ECG) Abnormalities [Day 49]

  5. Number of Participants with Clinical Laboratory Abnormalities [Day 49]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy adult males aged between 19 and 55 at screening

  • 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

  • Systolic blood pressure below 90 mmHg or above 140 mmHg

  • 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

  • A person who exhibits any of the following results from a 12-lead ECG test at the time of screening:

  • 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 ;

  • glomerular filtration rate (eGFR, CKD-EPI) < 60 mL/min/1.73 m2

  • WBC count < 3500/μL

  • Absolute neutrophil count (ANC) < 1500/μL

  • AST/ALT > 1.5 X ULN

  • 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.
Responsible Party:
NEXTGEN Bioscience
ClinicalTrials.gov Identifier:
NCT05079425
Other Study ID Numbers:
  • NXC736-001
First Posted:
Oct 15, 2021
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 15, 2021