A Dose-escalation Study of AND017 in Healthy Subjects

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751539
• Other study ID #: BB-AND017AU001
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: May 2021
• Source: Kind Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AND017 single dose
AND017 administrated as oral single-dose on Day 1 in Part A
• AND017 multiple dose
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

Locations

Country	Name	City	State
Australia	Scientia Clinical Research	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kind Pharmaceuticals LLC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluations	Incidents of AE and abnormal laboratory tests	17 Days
Secondary	Plasma Cmax of AND017	The plasma Cmax of AND017 by single dose administration	1 day
Secondary	Plasma Tmax of AND017	The plasma Tmax of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10	1 day and 10 days
Secondary	Plasma t1/2 of AND017	The plasma T1/2 of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10	1 day and 10 days
Secondary	Plasma AUC of AND017	The plasma AUCs of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10	1 day and 10 days
Secondary	Plasma CL/F of AND017	The plasma CL/F of AND017 after single dose administration	1 day
Secondary	Plasma Vz/F of AND017	The plasma Vz/F of AND017 after single dose administration	1 day
Secondary	Plasma MRT of AND017	The plasma MRT of AND017 after single dose administration	1 day
Secondary	Plasma ?z of AND017	The plasma ?z of AND017 after single dose administration	1 day
Secondary	Plasma %AUCex of AND017	The plasma %AUCex of AND017 after single dose administration	1 day
Secondary	Plasma Css,min of AND017	The plasma Css,min of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma Css,max of AND017	The plasma Css,max of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma Css,avg of AND017	The plasma Css,avg of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma CLss/F of AND017	The plasma CLss/F of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma Vss/F of AND017	The plasma Vss/F of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma Rac(AUC) of AND017	The plasma Rac(AUC) of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	Plasma DF of AND017	The plasma DF of AND017 by multiple administration for 10 consecutive days	10 days
Secondary	PD parameters	Change from baseline levels of EPO	17 days
Secondary	PD parameters	Change from baseline levels of HB	17 days
Secondary	PD parameters	Change from baseline levels of RET	17 days