A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults

Launched by SHENZHEN NEWDEL BIOTECH, CO., LTD · Apr 10, 2024

Keywords

ClinConnect Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects.

The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1) Healthy volunteers, both male and female;
• • 2) age: 18-45 years old;
• • 3) Weight: Male ≥ 50kg, female ≥ 45kg, 19 ≤ BMI ≤ 26 (BMI=weight (kg)/height2 (m2);
• • 4) Subject is in generally good health according to physical examination;
• • 5) Subjects voluntarily participate in clinical trials and sign a written informed consent form.
• Exclusion Criteria:
• • 1) Participated in any other clinical trial of drugs within the three months prior to the trial;
• • 2) Any disease that may affect the safety of the clinical trial or the in vivo process of the investigational drug;
• • 3) Allergic constitution: If there is a history of drug, food allergies, or skin allergies;
• • 4) Any drug that inhibits or induces liver metabolism has been used within 28 days prior to the use of the investigational drug;
• • 5) Have used any medication (including Chinese herbal medicine) and health supplements within 14 days prior to administration;
• • 6) Have special requirements for diet and cannot follow a unified diet;
• • 7) Subjects with a history of intolerance to venipuncture blood collection, or fear of needles and hemophobia;
• • 8) Drinking alcohol, tea, or caffeinated beverages for a long period of time or within 48 hours prior to administration;
• • 9) Previous alcoholics, or frequent alcohol consumption within 6 months prior to administration; or consumption of any alcohol-containing product within 24 hours prior to administration ;
• • 10) Blood donation or blood loss (greater than 450 mL) within 3 months prior to administration, or planning to donate blood during the study period or within 3 months after the end of the study ;
• • 11) Acute illness occurred during pre study screening or prior to administration;
• • 12) Subjects who have any diet that can alter liver enzymes activity within 24 hours prior to administration;
• • 13) Have undergone surgery within the first three months of screening, or plan to undergo surgery during the study period;
• • 14) Previous drug addict and drug abuse;
• • 15) Smoking more than 5 cigarettes per day within the first 14 days of screening, or unable to withdraw nicotine-containing products during the study;
• • 16) Subjects who smoke or use nicotine-containing products from screening to hospitalization;
• • 17) Abnormal and clinically significant electrocardiogram results before screening or administration, or QTcF(QTcF - Fridericia's correction formula)\>450 msec;
• • 18) Positive results of nicotine test;
• • 19) Alcohol breath test, with test results greater than 0.0mg/100 mL;
• • 20) Positive urine drug test at screening;
• • 21) Pregnant or lactating women;
• • 22) Have plan for fertility or reluctance use any contraception during the study period and within 6 months after the end of the trial;
• • 23) Subjects with other factors that are not suitable for participation in this study as judged by the investigator.