A Dose-escalation Study of AND017 in Healthy Subjects

NCT ID: NCT04751539

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-16
• Study Completion Date: 2019-02-11

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AND017 single dose escalation

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

Group Type: EXPERIMENTAL

AND017 single dose

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

AND017 multiple dose

Intervention Type: DRUG

AND017 administrated once daily from Day 1 to Day 10 in Part B

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

AND017 single dose

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

Intervention Type: DRUG

AND017 multiple dose

AND017 administrated once daily from Day 1 to Day 10 in Part B

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kind Pharmaceuticals LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yusha Zhu, MD PhD

Role: STUDY_DIRECTOR

Kind Pharmaceuticals LLC

Locations

Scientia Clinical Research

Randwick, New South Wales, Australia

Countries

Australia

Other Identifiers

BB-AND017AU001

Identifier Type: -

Identifier Source: org_study_id