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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy
• Intervention / Treatment: Drug: ND-003 40mg; Drug: ND-003 placebo 40mg; Drug: ND-003 80mg; Drug: ND-003 placebo 80mg; Drug: ND-003 160mg; Drug: ND-003 placebo 160mg; Drug: ND-003 240mg; Drug: ND-003 placebo 240mg; Drug: ND-003 300mg; Drug: ND-003 placebo 300mg; Drug: MAD_ND003_Dose 1; Drug: MAD_placebo_Dose 1; Drug: MAD_ND003_Dose 2; Drug: MAD_placebo_Dose 2; Drug: MAD_ND003_Dose 3; Drug: MAD_ placebo_Dose 3; Drug: Food effect_Cohort 1; Drug: Food effect_Cohort 2

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ND-003 40mg; SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.	Drug: ND-003 40mg; Participants receive 40mg ND-003 tablets once.; Drug: ND-003 placebo 40mg; Participants receive placebo tablet matching to receive 40mg of ND-003.
Experimental: ND-003 80mg; SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.	Drug: ND-003 80mg; Participants receive 80mg ND-003 tablets once.; Drug: ND-003 placebo 80mg; Participants receive placebo tablet matching to receive 80mg of ND-003.
Experimental: ND-003 160mg; SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.	Drug: ND-003 160mg; Participants receive 160mg ND-003 tablets once.; Drug: ND-003 placebo 160mg; Participants receive placebo tablet matching to receive 160mg of ND-003.
Experimental: ND-003 240mg; SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.	Drug: ND-003 240mg; Participants receive 240mg ND-003 tablets once.; Drug: ND-003 placebo 240mg; Participants receive placebo tablet matching to receive 240mg of ND-003.
Experimental: ND-003 300mg; SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.	Drug: ND-003 300mg; Participants receive 300mg ND-003 tablets once.; Drug: ND-003 placebo 300mg; Participants receive placebo tablet matching to receive 300mg of ND-003.
Experimental: ND-003_Dose 1; MAD （Multiple Ascending Dose）Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.	Drug: MAD_ND003_Dose 1; Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.; Drug: MAD_placebo_Dose 1; Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 1
Experimental: ND-003_Dose 2; MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.	Drug: MAD_ND003_Dose 2; Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.; Drug: MAD_placebo_Dose 2; Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 2
Experimental: ND-003_Dose 3; MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days.	Drug: MAD_ND003_Dose 3; Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.; Drug: MAD_ placebo_Dose 3; Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 3
Experimental: Food effect_Cohort 1; Food effect Cohort 1: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fasting condition in day 1 and then in fed condition in day 8.	Drug: Food effect_Cohort 1; Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
Experimental: Food effect_Cohort 2; Food effect Cohort 2: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fed condition in day 1 and then in fasting condition in day 8.	Drug: Food effect_Cohort 2; Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE)	Number and type of participants with treatment-related adverse events	through study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum concentration (Cmax)	The drug maximum concentration reaches when the absorption rate is equal to the elimination rate at a single dose.	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
Time to maximum concentration (Tmax)	Time required to reach peak drug concentration after a single administration.	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
Elimination Half-life (t1/2)	Elimination Half-life (t1/2) refers to the time required to eliminate 50% of the drug from the body.	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
Clearance (CLz/F)	Clearance (CLz/F) describes how the body effectively eliminate drugs from the systemic circulation, typically defined as the volume of drug-containing plasma eliminated from the body per unit time.	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
AUC from time 0 to last time of quantifiable concentration (AUC0-t)	Area under the plasma concentration-time curve from the initial administration to the last measurable concentration point.	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

Collaborators and Investigators

• Sponsor: Shenzhen NewDEL Biotech, Co., Ltd
• Collaborators: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
• Investigators: Principal Investigator: Shaojun Shi, PhD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ND003-I-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No