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

NCT06360874 | Enrolling By Invitation Phase 1

• 1 other identifier: ND003-I-06
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AE)

  Number and type of participants with treatment-related adverse events

  through study completion, an average of 1 month

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (10)

ND-003 40mg

EXPERIMENTAL

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

Drug: ND-003 40mg; Drug: ND-003 placebo 40mg

ND-003 80mg

EXPERIMENTAL

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

Drug: ND-003 80mg; Drug: ND-003 placebo 80mg

ND-003 160mg

EXPERIMENTAL

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

Drug: ND-003 160mg; Drug: ND-003 placebo 160mg

ND-003 240mg

EXPERIMENTAL

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

Drug: ND-003 240mg; Drug: ND-003 placebo 240mg

ND-003 300mg

EXPERIMENTAL

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

Drug: ND-003 300mg; Drug: ND-003 placebo 300mg

ND-003_Dose 1

EXPERIMENTAL

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; Drug: MAD_placebo_Dose 1

ND-003_Dose 2

EXPERIMENTAL

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; Drug: MAD_placebo_Dose 2

ND-003_Dose 3

EXPERIMENTAL

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; Drug: MAD_ placebo_Dose 3

Food effect_Cohort 1

EXPERIMENTAL

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

Food effect_Cohort 2

EXPERIMENTAL

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

Interventions

ND-003 40mg DRUG

Participants receive 40mg ND-003 tablets once.

ND-003 40mg

ND-003 placebo 40mg DRUG

Participants receive placebo tablet matching to receive 40mg of ND-003.

ND-003 40mg

ND-003 80mg DRUG

Participants receive 80mg ND-003 tablets once.

ND-003 80mg

ND-003 placebo 80mg DRUG

Participants receive placebo tablet matching to receive 80mg of ND-003.

ND-003 80mg

ND-003 160mg DRUG

Participants receive 160mg ND-003 tablets once.

ND-003 160mg

ND-003 placebo 160mg DRUG

Participants receive placebo tablet matching to receive 160mg of ND-003.

ND-003 160mg

ND-003 240mg DRUG

Participants receive 240mg ND-003 tablets once.

ND-003 240mg

ND-003 placebo 240mg DRUG

Participants receive placebo tablet matching to receive 240mg of ND-003.

ND-003 240mg

ND-003 300mg DRUG

Participants receive 300mg ND-003 tablets once.

ND-003 300mg

ND-003 placebo 300mg DRUG

Participants receive placebo tablet matching to receive 300mg of ND-003.

ND-003 300mg

MAD_ND003_Dose 1 DRUG

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

ND-003_Dose 1

MAD_placebo_Dose 1 DRUG

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1

ND-003_Dose 1

MAD_ND003_Dose 2 DRUG

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

ND-003_Dose 2

MAD_placebo_Dose 2 DRUG

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2

ND-003_Dose 2

MAD_ND003_Dose 3 DRUG

Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.

ND-003_Dose 3

MAD_ placebo_Dose 3 DRUG

Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3

ND-003_Dose 3

Food effect_Cohort 1 DRUG

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.

Food effect_Cohort 1

Food effect_Cohort 2 DRUG

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.

Food effect_Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) Healthy volunteers, both male and female;
• \) age: 18-45 years old;
• \) Weight: Male ≥ 50kg, female ≥ 45kg, 19 ≤ BMI ≤ 26 (BMI=weight (kg)/height2 (m2);
• \) Subject is in generally good health according to physical examination;
• \) Subjects voluntarily participate in clinical trials and sign a written informed consent form.

You may not qualify if:

• \) Participated in any other clinical trial of drugs within the three months prior to the trial;
• \) Any disease that may affect the safety of the clinical trial or the in vivo process of the investigational drug;
• \) Allergic constitution: If there is a history of drug, food allergies, or skin allergies;
• \) Any drug that inhibits or induces liver metabolism has been used within 28 days prior to the use of the investigational drug;
• \) Have used any medication (including Chinese herbal medicine) and health supplements within 14 days prior to administration;
• \) Have special requirements for diet and cannot follow a unified diet;
• \) Subjects with a history of intolerance to venipuncture blood collection, or fear of needles and hemophobia;
• \) Drinking alcohol, tea, or caffeinated beverages for a long period of time or within 48 hours prior to administration;
• \) 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 ;
• \) 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 ;
• \) Acute illness occurred during pre study screening or prior to administration;
• \) Subjects who have any diet that can alter liver enzymes activity within 24 hours prior to administration;
• \) Have undergone surgery within the first three months of screening, or plan to undergo surgery during the study period;
• \) Previous drug addict and drug abuse;
• \) Smoking more than 5 cigarettes per day within the first 14 days of screening, or unable to withdraw nicotine-containing products during the study;

Sponsors & Collaborators

• Shenzhen NewDEL Biotech, Co., Ltd: lead
• Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.: collaborator

Study Sites (1)

Union Hospital, Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Study Officials

• Shaojun Shi, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 11, 2024
• Study Start: May 9, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-03

Locations

CN (1)