Clinical trial NCT04751539: A Dose-escalation Study of AND017 in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Kind Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Safety evaluations
timeFrame: 17 Days
Secondary outcomes:
measure: Plasma Cmax of AND017
timeFrame: 1 day
measure: Plasma Tmax of AND017
timeFrame: 1 day and 10 days
measure: Plasma t1/2 of AND017
timeFrame: 1 day and 10 days
measure: Plasma AUC of AND017
timeFrame: 1 day and 10 days
measure: Plasma CL/F of AND017
timeFrame: 1 day
measure: Plasma Vz/F of AND017
timeFrame: 1 day
measure: Plasma MRT of AND017
timeFrame: 1 day
measure: Plasma λz of AND017
timeFrame: 1 day
measure: Plasma %AUCex of AND017
timeFrame: 1 day
measure: Plasma Css,min of AND017
timeFrame: 10 days
measure: Plasma Css,max of AND017
timeFrame: 10 days
measure: Plasma Css,avg of AND017
timeFrame: 10 days
measure: Plasma CLss/F of AND017
timeFrame: 10 days
measure: Plasma Vss/F of AND017
timeFrame: 10 days
measure: Plasma Rac(AUC) of AND017
timeFrame: 10 days
measure: Plasma DF of AND017
timeFrame: 10 days
measure: PD parameters
timeFrame: 17 days
measure: PD parameters
timeFrame: 17 days
measure: PD parameters
timeFrame: 17 days
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
Study officials:
affiliation: Kind Pharmaceuticals LLC
name: Yusha Zhu, MD PhD
role: STUDY_DIRECTOR
References: