A First-in-human Single Ascending Dose/Multiple Ascending Dose Study of ENN0403 in Healthy Subjects

Summary

This is a FIH, randomized, double- blind, placebo-controlled, dose -escalation study to investigate the safety, tolerability, PK, and PD of ENN0403 after single and multiple oral dose administration in healthy adult subjects. The study will include 2 parts which will proceed in a parallel staggered manner: Part A, a single ascending dose (SAD) study and Part B, a multiple ascending dose (MAD) study.

Approximately 80 healthy adult subjects will be enrolled at a single site in Australia, in up to 6 cohorts in Part A (SAD study), including a Food Effect (FE) study, and up to 4 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is once daily use for 14 consecutive days. Each cohort will include 8 subjects (6 receiving ENN0403 and 2 receiving placebo). Each subject will be enrolled in only 1 cohort and receive only one dose regimen in this study.

Dosing will be escalated in a sequential fashion, contingent on a review of safety, tolerability, and available PK data of the previous dose level by a Safety Review Committee (SRC). The proposed dose levels/ dosing frequency of ENN0403 may be adjusted over the course of the whole study and cohorts may be added or removed depending on the emerging safety, tolerability, and available PK data.

Conditions

• Healthy

Interventions

DRUG

ENN0403 1mg

ENN0403 capsules for oral use

DRUG

ENN0403 4mg

ENN0403 capsules for oral use

DRUG

ENN0403 10mg

ENN0403 capsules for oral use

DRUG

ENN0403 20mg

ENN0403 capsules for oral use

DRUG

ENN0403 30mg

ENN0403 capsules for oral use

DRUG

ENN0403 20mg (Fed)

ENN0403 capsules for oral use

DRUG

ENN0403 6mg QD X 14 Days

ENN0403 capsules for oral use

DRUG

ENN0403 12mg QD X 14 Days

ENN0403 capsules for oral use

DRUG

ENN0403 20mg QD X 14 Days

ENN0403 capsules for oral use

DRUG

Placebo

Placebo capsules for oral use

Sponsors & Collaborators

• EnnovaBio

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-17

Primary Completion

2022-05-16

Completion

2022-05-16

Countries

• Australia

Study Locations