NCT04751539
Completed
Phase 1
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
ConditionsHealthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Kind Pharmaceuticals LLC
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Safety evaluations
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Placebo
Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
Intervention: Placebo
AND017 single dose escalation
Subjects will be administrated with single dose of AND017 capsule from 1 mg to 50 mg during Part A.
Intervention: AND017 single dose
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.
Intervention: AND017 multiple dose
Outcomes
Primary Outcomes
Safety evaluations
Time Frame: 17 Days
Incidents of AE and abnormal laboratory tests
Secondary Outcomes
- Plasma Cmax of AND017(1 day)
- Plasma CL/F of AND017(1 day)
- Plasma CLss/F of AND017(10 days)
- Plasma %AUCex of AND017(1 day)
- Plasma λz of AND017(1 day)
- Plasma Css,max of AND017(10 days)
- Plasma Css,avg of AND017(10 days)
- Plasma Vss/F of AND017(10 days)
- Plasma t1/2 of AND017(1 day and 10 days)
- Plasma Rac(AUC) of AND017(10 days)
- PD parameters(17 days)
- Plasma Tmax of AND017(1 day and 10 days)
- Plasma AUC of AND017(1 day and 10 days)
- Plasma Vz/F of AND017(1 day)
- Plasma MRT of AND017(1 day)
- Plasma Css,min of AND017(10 days)
- Plasma DF of AND017(10 days)
Study Sites (1)
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