MedTrace Logo

A Dose-escalation Study of AND017 in Healthy Subjects

NCT04751539 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-05-11

No results posted yet for this study

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

Interventions

DRUG

AND017 single dose

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

DRUG

AND017 multiple dose

AND017 administrated once 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

Sponsors & Collaborators

  • Kind Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Yusha Zhu, MD PhD · Kind Pharmaceuticals LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-02-11
Completion
2019-02-11

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04751539 on ClinicalTrials.gov