NCT05506540 is a Phase 1 clinical trial of ENN0403 1mg in Healthy, sponsored by EnnovaBio.

Who is sponsoring NCT05506540?

NCT05506540 is sponsored by EnnovaBio.

What drugs are being tested in NCT05506540?

Interventions in NCT05506540: ENN0403 1mg, ENN0403 4mg, ENN0403 10mg, ENN0403 20mg, ENN0403 30mg, ENN0403 20mg (Fed), ENN0403 6mg QD X 14 Days, ENN0403 12mg QD X 14 Days, ENN0403 20mg QD X 14 Days, Placebo.

Is NCT05506540 still recruiting?

NCT05506540 is currently completed. Last updated 19 September 2024.

Last reviewed 2024-09-19 · How we verify

NCT05506540

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 19 September 2024

What this trial tests

Phase 1 trial testing ENN0403 1mg in Healthy in 69 participants. Completed in 16 May 2022.

Timeline

17 February 2021

Primary endpoint
16 May 2022

16 May 2022

Quick facts

Lead sponsor	EnnovaBio
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	17 February 2021
Primary completion	16 May 2022
Estimated completion	16 May 2022
Sites	1 location across Australia

Drugs / interventions tested

ENN0403 1mg
ENN0403 4mg — full drug profile →
ENN0403 10mg — full drug profile →
ENN0403 20mg
ENN0403 30mg — full drug profile →
ENN0403 20mg (Fed)
ENN0403 6mg QD X 14 Days — full drug profile →
ENN0403 12mg QD X 14 Days — full drug profile →
ENN0403 20mg QD X 14 Days
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

EnnovaBio — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05506540 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EnnovaBio
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05506540.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing