A Dose-escalation Study of AND017 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AND017 single dose; Drug: AND017 multiple dose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Scientia Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AND017 single dose escalation; Subjects will be administrated with single dose of AND017 capsule from 1 mg to 50 mg during Part A.	Drug: AND017 single dose; AND017 administrated as oral single-dose on Day 1 in Part A
Placebo Comparator: 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.	Drug: AND017 multiple dose; AND017 administrated once daily from Day 1 to Day 10 in Part B
Placebo Comparator: Placebo; Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B	Drug: Placebo; Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluations	Incidents of AE and abnormal laboratory tests	17 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Cmax of AND017	The plasma Cmax of AND017 by single dose administration	1 day
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
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
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
Plasma CL/F of AND017	The plasma CL/F of AND017 after single dose administration	1 day
Plasma Vz/F of AND017	The plasma Vz/F of AND017 after single dose administration	1 day
Plasma MRT of AND017	The plasma MRT of AND017 after single dose administration	1 day
Plasma λz of AND017	The plasma λz of AND017 after single dose administration	1 day
Plasma %AUCex of AND017	The plasma %AUCex of AND017 after single dose administration	1 day
Plasma Css,min of AND017	The plasma Css,min of AND017 by multiple administration for 10 consecutive days	10 days
Plasma Css,max of AND017	The plasma Css,max of AND017 by multiple administration for 10 consecutive days	10 days
Plasma Css,avg of AND017	The plasma Css,avg of AND017 by multiple administration for 10 consecutive days	10 days
Plasma CLss/F of AND017	The plasma CLss/F of AND017 by multiple administration for 10 consecutive days	10 days
Plasma Vss/F of AND017	The plasma Vss/F of AND017 by multiple administration for 10 consecutive days	10 days
Plasma Rac(AUC) of AND017	The plasma Rac(AUC) of AND017 by multiple administration for 10 consecutive days	10 days
Plasma DF of AND017	The plasma DF of AND017 by multiple administration for 10 consecutive days	10 days
PD parameters	Change from baseline levels of EPO	17 days
PD parameters	Change from baseline levels of HB	17 days
PD parameters	Change from baseline levels of RET	17 days

Collaborators and Investigators

• Sponsor: Kind Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): February 11, 2019
• Study Completion (Actual): February 11, 2019

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: BB-AND017AU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No