A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
NCT ID: NCT06360874
Last Updated: 2024-05-30
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
PHASE1
104 participants
INTERVENTIONAL
2024-05-09
2025-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ND-003 40mg
SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
ND-003 40mg
Participants receive 40mg ND-003 tablets once.
ND-003 placebo 40mg
Participants receive placebo tablet matching to receive 40mg of ND-003.
ND-003 80mg
SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
ND-003 80mg
Participants receive 80mg ND-003 tablets once.
ND-003 placebo 80mg
Participants receive placebo tablet matching to receive 80mg of ND-003.
ND-003 160mg
SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
ND-003 160mg
Participants receive 160mg ND-003 tablets once.
ND-003 placebo 160mg
Participants receive placebo tablet matching to receive 160mg of ND-003.
ND-003 240mg
SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
ND-003 240mg
Participants receive 240mg ND-003 tablets once.
ND-003 placebo 240mg
Participants receive placebo tablet matching to receive 240mg of ND-003.
ND-003 300mg
SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
ND-003 300mg
Participants receive 300mg ND-003 tablets once.
ND-003 placebo 300mg
Participants receive placebo tablet matching to receive 300mg of ND-003.
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.
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.
MAD_placebo_Dose 1
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1
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.
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.
MAD_placebo_Dose 2
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2
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.
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.
MAD_ placebo_Dose 3
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3
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 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.
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.
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.
Interventions
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ND-003 40mg
Participants receive 40mg ND-003 tablets once.
ND-003 placebo 40mg
Participants receive placebo tablet matching to receive 40mg of ND-003.
ND-003 80mg
Participants receive 80mg ND-003 tablets once.
ND-003 placebo 80mg
Participants receive placebo tablet matching to receive 80mg of ND-003.
ND-003 160mg
Participants receive 160mg ND-003 tablets once.
ND-003 placebo 160mg
Participants receive placebo tablet matching to receive 160mg of ND-003.
ND-003 240mg
Participants receive 240mg ND-003 tablets once.
ND-003 placebo 240mg
Participants receive placebo tablet matching to receive 240mg of ND-003.
ND-003 300mg
Participants receive 300mg ND-003 tablets once.
ND-003 placebo 300mg
Participants receive placebo tablet matching to receive 300mg of ND-003.
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.
MAD_placebo_Dose 1
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1
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.
MAD_placebo_Dose 2
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2
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.
MAD_ placebo_Dose 3
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
UNKNOWN
Shenzhen NewDEL Biotech, Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shaojun Shi, PhD
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Other Identifiers
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ND003-I-06
Identifier Type: -
Identifier Source: org_study_id
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