Status:
COMPLETED
A Dose-escalation Study of AND017 in Healthy Subjects
Lead Sponsor:
Kind Pharmaceuticals LLC
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 do...
Eligibility Criteria
Inclusion
- BMI within 18.0-30.0 kg/m2 (inclusive)
- Blood Pressure (BP) and 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities during screening;
- No clinically significant abnormal values in physical examination, clinical laboratory tests, liver function or kidney function;
Exclusion
- 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%);
- Subjects with Hb: male \<120 g/L or \>160 g/L, female \<110 g/L or \>150 g/L;
- Subjects with any abnormalities of hematology during screening: Mean corpuscular volume (MCV), platelet count, serum iron, ferritin;
- Subjects with a history of medical treatment or disease likely to increase the risk of bleeding or disturbance of blood coagulation;
- History of deep vein thrombosis, stoke, transient ischemic attack, pulmonary embolism or other thrombosis-related condition within the last five years;
- History of myocardial infarction, heart failure or acute coronary syndrome;
- Evidence of active peptic, duodenal or esophageal ulcer disease at screening;
- History of pulmonary artery hypertension;
- History of sensitivity to heparin or heparin-induced thrombocytopenia;
- Subjects with major illness or surgery within past 3 months prior to screening, or planned surgery during study;
- Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
- 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.
- 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;
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2019
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04751539
Start Date
July 16 2018
End Date
February 11 2019
Last Update
May 11 2021
Active Locations (1)
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1
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031