Clinical trial NCT06360874: A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
Official title: Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shenzhen NewDEL Biotech, Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
First posted: 2024-04-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults

Detailed description: 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.

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.

Primary outcomes:
measure: Adverse Events (AE)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: maximum concentration (Cmax)
timeFrame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Time to maximum concentration (Tmax)
timeFrame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Elimination Half-life (t1/2)
timeFrame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: Clearance (CLz/F)
timeFrame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
measure: AUC from time 0 to last time of quantifiable concentration (AUC0-t)
timeFrame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Shaojun Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: