Healthy
Conditions
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.
Interventions
DRUGND-003 40mg
Participants receive 40mg ND-003 tablets once.
DRUGND-003 placebo 40mg
Participants receive placebo tablet matching to receive 40mg of ND-003.
DRUGND-003 80mg
Participants receive 80mg ND-003 tablets once.
DRUGND-003 placebo 80mg
Participants receive placebo tablet matching to receive 80mg of ND-003.
DRUGND-003 160mg
Participants receive 160mg ND-003 tablets once.
DRUGND-003 placebo 160mg
Participants receive placebo tablet matching to receive 160mg of ND-003.
DRUGND-003 240mg
Participants receive 240mg ND-003 tablets once.
DRUGND-003 placebo 240mg
Participants receive placebo tablet matching to receive 240mg of ND-003.
DRUGND-003 300mg
Participants receive 300mg ND-003 tablets once.
DRUGND-003 placebo 300mg
Participants receive placebo tablet matching to receive 300mg of ND-003.
DRUGMAD_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.
DRUGMAD_placebo_Dose 1
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 1
DRUGMAD_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.
DRUGMAD_placebo_Dose 2
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 2
DRUGMAD_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.
DRUGMAD_ placebo_Dose 3
Participants will orally administrated the placebo tablets matching to the MAD\_ND003\_Dose 3
DRUGFood 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.
DRUGFood 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.
Sponsors
Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
Shenzhen NewDEL Biotech, Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | through study completion, an average of 1 month | Number and type of participants with treatment-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed