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

NewDEL Biotech

Status and phase: Invitation-only; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06360874

ND003-I-06

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 10 patient groups

ND-003 40mg

Experimental group

Description:

SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.

Treatment:

Drug: ND-003 placebo 40mg

Drug: ND-003 40mg

ND-003 80mg

Experimental group

Description:

SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.

Treatment:

Drug: ND-003 placebo 80mg

Drug: ND-003 80mg

ND-003 160mg

Experimental group

Description:

SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.

Treatment:

Drug: ND-003 placebo 160mg

Drug: ND-003 160mg

ND-003 240mg

Experimental group

Description:

SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.

Treatment:

Drug: ND-003 240mg

Drug: ND-003 placebo 240mg

ND-003 300mg

Experimental group

Description:

SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.

Treatment:

Drug: ND-003 placebo 300mg

Drug: ND-003 300mg

ND-003_Dose 1

Experimental group

Description:

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.

Treatment:

Drug: MAD_ND003_Dose 1

Drug: MAD_placebo_Dose 1

ND-003_Dose 2

Experimental group

Description:

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.

Treatment:

Drug: MAD_ND003_Dose 2

Drug: MAD_placebo_Dose 2

ND-003_Dose 3

Experimental group

Description:

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.

Treatment:

Drug: MAD_ND003_Dose 3

Drug: MAD_ placebo_Dose 3

Food effect_Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Food effect_Cohort 1

Food effect_Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Food effect_Cohort 2