A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)

This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.

Start Date12 Dec 2024

Sponsor / Collaborator

EnnovaBio Australia Pharmaceuticals Pty Ltd

NCT06632613

/ RecruitingPhase 2

A Phase 2 Clinical Study Evaluating the Efficacy and Safety of ENN0403 in Patients At High Risk for Acute Kidney Injury Following Elective Cardiac Surgery Requiring Cardiopulmonary Bypass

The is a two-stage study. Stage 1 is to evaluate the safety, tolerability, PK and PD of ENN0403 in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass. Stage 2 is to evaluate the efficacy, safety, PK and PD of ENN0403 to prevent and treat AKI after multiple administraions in patients at high risk of AKI following elective cardiac surgery requring cardiopulmonary bypass.

Start Date05 Nov 2024

Sponsor / Collaborator

EnnovaBio Australia Pharmaceuticals Pty Ltd

CTR20213238

/ CompletedPhase 1

单中心、随机、双盲及安慰剂对照评价ENN0403胶囊在健康受试者中单次、多次给药后人体安全性、耐受性及药代、药效动力学I期临床研究

[Translation] A single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ENN0403 capsules after single and multiple administrations in healthy subjects

主要目的：评价中国健康成人受试者单次、多次口服ENN0403胶囊后的安全性和耐受性。次要目的：评价中国健康成人受试者单次、多次口服ENN0403胶囊后的药代动力学特征。探索性目的：评价中国健康成人受试者单次和多次给药后，ENN0403对血浆中靶点活性相关的PD影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of ENN0403 capsules after single and multiple oral administration in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacokinetic characteristics of ENN0403 capsules after single and multiple oral administration in healthy Chinese adult subjects. Exploratory objective: To evaluate the PD effects of ENN0403 on target activity in plasma after single and multiple administration in healthy Chinese adult subjects.

Start Date11 Feb 2022

Sponsor / Collaborator

EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,

100 Clinical Results associated with ENN-0403

100 Translational Medicine associated with ENN-0403

100 Patents (Medical) associated with ENN-0403

100 Deals associated with ENN-0403

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic macular oedema	Phase 2	China	EnnovaBio Australia Pharmaceuticals Pty Ltd	12 Dec 2024
Diabetic macular oedema	Phase 2	China	Shanghai Ennovabio Pharmaceuticals Co. Ltd.	12 Dec 2024
Acute Kidney Injury	Phase 2	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	05 Nov 2024
Acute Kidney Injury	Phase 2	China	EnnovaBio Australia Pharmaceuticals Pty Ltd	05 Nov 2024
Nonalcoholic Steatohepatitis	Phase 1	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	11 Feb 2022
Sepsis	IND Approval	China	EnnovaBio Pharmaceuticals(zhejiang) Co., Ltd,	11 Mar 2024

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