A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Drug: ND-003 40mg
- Drug: ND-003 placebo 40mg
- Drug: ND-003 80mg
- Drug: ND-003 placebo 80mg
- Drug: ND-003 160mg
- Drug: ND-003 placebo 160mg
- Drug: ND-003 240mg
- Drug: ND-003 placebo 240mg
- Drug: ND-003 300mg
- Drug: ND-003 placebo 300mg
- Drug: MAD_ND003_Dose 1
- Drug: MAD_placebo_Dose 1
- Drug: MAD_ND003_Dose 2
- Drug: MAD_placebo_Dose 2
- Drug: MAD_ND003_Dose 3
- Drug: MAD_ placebo_Dose 3
- Drug: Food effect_Cohort 1
- Drug: Food effect_Cohort 2
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 Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Shaojun Shi, PhD
- Phone Number: +86-13871312811
- Email: sjshicn@163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Union Hospital, Tongji Medical College Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: ND-003 40mg
SAD(Single Ascending Dose) Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once.
|
Participants receive 40mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 40mg of ND-003.
|
|
Experimental: ND-003 80mg
SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once.
|
Participants receive 80mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 80mg of ND-003.
|
|
Experimental: ND-003 160mg
SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once.
|
Participants receive 160mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 160mg of ND-003.
|
|
Experimental: ND-003 240mg
SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once.
|
Participants receive 240mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 240mg of ND-003.
|
|
Experimental: ND-003 300mg
SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once.
|
Participants receive 300mg ND-003 tablets once.
Participants receive placebo tablet matching to receive 300mg of ND-003.
|
|
Experimental: 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.
|
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 1
|
|
Experimental: 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.
|
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 2
|
|
Experimental: 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.
|
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 3
|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events (AE)
Time Frame: through study completion, an average of 1 month
|
Number and type of participants with treatment-related adverse events
|
through study completion, an average of 1 month
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
maximum concentration (Cmax)
Time Frame: 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.
|
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)
Time Frame: 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.
|
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)
Time Frame: 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.
|
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)
Time Frame: 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.
|
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)
Time Frame: 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.
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Shaojun Shi, PhD, Wuhan Union Hospital, China
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- ND003-I-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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