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

Phase 1

• Conditions: Healthy
• Interventions: Drug: ND-003 160mg; Drug: ND-003 40mg; Drug: ND-003 80mg; Drug: ND-003 300mg; Drug: ND-003 240mg; Drug: MAD_ND003_Dose 1; Drug: MAD_ND003_Dose 2; Drug: MAD_ND003_Dose 3; Drug: Food effect_Cohort 1; Drug: Food effect_Cohort 2; Drug: ND-003 placebo 40mg; Drug: ND-003 placebo 300mg; Drug: MAD_placebo_Dose 2; Drug: ND-003 placebo 80mg; Drug: MAD_placebo_Dose 1; Drug: ND-003 placebo 160mg; Drug: ND-003 placebo 240mg; Drug: MAD_ placebo_Dose 3

• Registration Number: NCT06360874
• Lead Sponsor: Shenzhen NewDEL Biotech, Co., Ltd

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-10
• Study First Posted: 2024-04-11
• Study Start: 2024-05-09
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ND-003 160mg	ND-003 160mg	SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
ND-003 40mg	ND-003 placebo 40mg	SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
ND-003 40mg	ND-003 40mg	SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
ND-003 80mg	ND-003 80mg	SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
ND-003 300mg	ND-003 300mg	SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
ND-003 300mg	ND-003 placebo 300mg	SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
ND-003_Dose 2	MAD_placebo_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.
ND-003 80mg	ND-003 placebo 80mg	SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
ND-003 240mg	ND-003 240mg	SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
ND-003_Dose 1	MAD_placebo_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.
ND-003 160mg	ND-003 placebo 160mg	SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
ND-003 240mg	ND-003 placebo 240mg	SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
ND-003_Dose 3	MAD_ placebo_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.
ND-003_Dose 1	MAD_ND003_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.
ND-003_Dose 2	MAD_ND003_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.
ND-003_Dose 3	MAD_ND003_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.
Food effect_Cohort 1	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.
Food effect_Cohort 2	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to maximum concentration (Tmax)	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 required to reach peak drug concentration after a single administration.
Clearance (CLz/F)	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) 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.
maximum concentration (Cmax)	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	The drug maximum concentration reaches when the absorption rate is equal to the elimination rate at a single dose.
Elimination Half-life (t1/2)	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) refers to the time required to eliminate 50% of the drug from the body.
AUC from time 0 to last time of quantifiable concentration (AUC0-t)	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	Area under the plasma concentration-time curve from the initial administration to the last measurable concentration point.

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China