A Dose-escalation Study of AND017 in Healthy Subjects

NCT04751539 | Completed Phase 1

• 1 other identifier: BB-AND017AU001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Safety evaluations

  Incidents of AE and abnormal laboratory tests

  17 Days

Secondary Outcomes (19)

• Plasma Cmax of AND017

  1 day

• Plasma Tmax of AND017

  1 day and 10 days

• Plasma t1/2 of AND017

  1 day and 10 days

• Plasma AUC of AND017

  1 day and 10 days

• Plasma CL/F of AND017

  1 day

Study Arms (3)

AND017 single dose escalation

EXPERIMENTAL

Subjects will be administrated with single dose of AND017 capsule from 1 mg to 50 mg during Part A.

Drug: AND017 single dose

AND017 repeated dose escalation

PLACEBO COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B

Drug: Placebo

Interventions

AND017 single dose DRUG

AND017 administrated as oral single-dose on Day 1 in Part A

AND017 single dose escalation

AND017 multiple dose DRUG

AND017 administrated once daily from Day 1 to Day 10 in Part B

AND017 repeated dose escalation

Placebo DRUG

Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Known or suspected history of drug abuse within the past 5 years or presence of drug abuse within 3 months before study;
• 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.
• 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;

Sponsors & Collaborators

• Kind Pharmaceuticals LLC: lead

Study Sites (1)

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Study Officials

• Yusha Zhu, MD PhD

  Kind Pharmaceuticals LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 12, 2021
• Study Start: July 16, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)