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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04751539




Registration number
NCT04751539
Ethics application status
Date submitted
28/01/2021
Date registered
12/02/2021
Date last updated
11/05/2021

Titles & IDs
Public title
A Dose-escalation Study of AND017 in Healthy Subjects
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AND017 Following Oral Single and Multiple Dose Administration
Secondary ID [1] 0 0
BB-AND017AU001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AND017 single dose
Treatment: Drugs - AND017 multiple dose
Treatment: Drugs - Placebo

Experimental: AND017 single dose escalation - Subjects will be administrated with single dose of AND017 capsule from 1 mg to 50 mg during Part A.

Placebo comparator: AND017 repeated dose escalation - Subjects will be administrated with repeated dose of AND017 from 4 mg to 30 mg for 10 consecutive days during Part B.

Placebo comparator: Placebo - Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B


Treatment: Drugs: AND017 single dose
AND017 administrated as oral single-dose on Day 1 in Part A

Treatment: Drugs: AND017 multiple dose
AND017 administrated once daily from Day 1 to Day 10 in Part B

Treatment: Drugs: Placebo
Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety evaluations
Timepoint [1] 0 0
17 Days
Secondary outcome [1] 0 0
Plasma Cmax of AND017
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Plasma Tmax of AND017
Timepoint [2] 0 0
1 day and 10 days
Secondary outcome [3] 0 0
Plasma t1/2 of AND017
Timepoint [3] 0 0
1 day and 10 days
Secondary outcome [4] 0 0
Plasma AUC of AND017
Timepoint [4] 0 0
1 day and 10 days
Secondary outcome [5] 0 0
Plasma CL/F of AND017
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
Plasma Vz/F of AND017
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
Plasma MRT of AND017
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
Plasma ?z of AND017
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Plasma %AUCex of AND017
Timepoint [9] 0 0
1 day
Secondary outcome [10] 0 0
Plasma Css,min of AND017
Timepoint [10] 0 0
10 days
Secondary outcome [11] 0 0
Plasma Css,max of AND017
Timepoint [11] 0 0
10 days
Secondary outcome [12] 0 0
Plasma Css,avg of AND017
Timepoint [12] 0 0
10 days
Secondary outcome [13] 0 0
Plasma CLss/F of AND017
Timepoint [13] 0 0
10 days
Secondary outcome [14] 0 0
Plasma Vss/F of AND017
Timepoint [14] 0 0
10 days
Secondary outcome [15] 0 0
Plasma Rac(AUC) of AND017
Timepoint [15] 0 0
10 days
Secondary outcome [16] 0 0
Plasma DF of AND017
Timepoint [16] 0 0
10 days
Secondary outcome [17] 0 0
PD parameters
Timepoint [17] 0 0
17 days
Secondary outcome [18] 0 0
PD parameters
Timepoint [18] 0 0
17 days
Secondary outcome [19] 0 0
PD parameters
Timepoint [19] 0 0
17 days

Eligibility
Key inclusion criteria
1. BMI within 18.0-30.0 kg/m2 (inclusive)
2. Blood Pressure (BP) and 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities during screening;
3. No clinically significant abnormal values in physical examination, clinical laboratory tests, liver function or kidney function;
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current or chronic history of liver disease or known hepatic or biliary abnormalities, including but not limited to ALT, alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
2. Subjects with Hb: male <120 g/L or >160 g/L, female <110 g/L or >150 g/L;
3. Subjects with any abnormalities of hematology during screening: Mean corpuscular volume (MCV), platelet count, serum iron, ferritin;
4. Subjects with a history of medical treatment or disease likely to increase the risk of bleeding or disturbance of blood coagulation;
5. History of deep vein thrombosis, stoke, transient ischemic attack, pulmonary embolism or other thrombosis-related condition within the last five years;
6. History of myocardial infarction, heart failure or acute coronary syndrome;
7. Evidence of active peptic, duodenal or esophageal ulcer disease at screening;
8. History of pulmonary artery hypertension;
9. History of sensitivity to heparin or heparin-induced thrombocytopenia;
10. Subjects with major illness or surgery within past 3 months prior to screening, or planned surgery during study;
11. Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
12. Donated blood >400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3months of screening; or donated blood >200 mL or significant blood loss equivalent to 200 mL within 1 month prior to screening.
13. Participation in any clinical study with an investigational drug, biologic or device within 4 weeks or 5 times the half-life of the specific drug/biologics (whichever is longer), prior to dosing;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/02/2019
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kind Pharmaceuticals LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.
Trial website
https://clinicaltrials.gov/study/NCT04751539
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yusha Zhu, MD PhD
Address 0 0
Kind Pharmaceuticals LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04751539