Healthy Volunteers
Conditions
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.
Interventions
DRUGAND017 single dose
AND017 administrated as oral single-dose on Day 1 in Part A
DRUGAND017 multiple dose
AND017 administrated once daily from Day 1 to Day 10 in Part B
DRUGPlacebo
Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
Sponsors
Kind Pharmaceuticals LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluations | 17 Days | Incidents of AE and abnormal laboratory tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Cmax of AND017 | 1 day | The plasma Cmax of AND017 by single dose administration |
| Plasma Tmax of AND017 | 1 day and 10 days | The plasma Tmax of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 |
| Plasma t1/2 of AND017 | 1 day and 10 days | The plasma T1/2 of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 |
| Plasma AUC of AND017 | 1 day and 10 days | The plasma AUCs of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 |
| Plasma CL/F of AND017 | 1 day | The plasma CL/F of AND017 after single dose administration |
| Plasma Vz/F of AND017 | 1 day | The plasma Vz/F of AND017 after single dose administration |
| Plasma λz of AND017 | 1 day | The plasma λz of AND017 after single dose administration |
| Plasma %AUCex of AND017 | 1 day | The plasma %AUCex of AND017 after single dose administration |
| Plasma MRT of AND017 | 1 day | The plasma MRT of AND017 after single dose administration |
| Plasma Css,max of AND017 | 10 days | The plasma Css,max of AND017 by multiple administration for 10 consecutive days |
| Plasma Css,avg of AND017 | 10 days | The plasma Css,avg of AND017 by multiple administration for 10 consecutive days |
| Plasma CLss/F of AND017 | 10 days | The plasma CLss/F of AND017 by multiple administration for 10 consecutive days |
| Plasma Vss/F of AND017 | 10 days | The plasma Vss/F of AND017 by multiple administration for 10 consecutive days |
| Plasma Rac(AUC) of AND017 | 10 days | The plasma Rac(AUC) of AND017 by multiple administration for 10 consecutive days |
| Plasma DF of AND017 | 10 days | The plasma DF of AND017 by multiple administration for 10 consecutive days |
| PD parameters | 17 days | Change from baseline levels of EPO |
| Plasma Css,min of AND017 | 10 days | The plasma Css,min of AND017 by multiple administration for 10 consecutive days |
Countries
Australia
Outcome results
None listed