Clinical Trials

1. BEL-X Clinical Trial Pipeline

 臨床規劃(英)-20221201

2. Phase I clinical trial (completed)

Evaluation:A Phase I, Dose Escalation and Extension Study to Evaluate the Safety, Tolerability and Preliminary Effects of Oral BEL-X in Patients With Advanced Refractory Solid Malignancies

IND:US FDA (#127857) & Taiwan FDA FDA、TFDA-20221123

Trial site:National Taiwan University Hospital  台大-20221123

National Cheng Kung University Hospital  成大-20221123

 

Period:2017.05-2020.04

Results:1. BEL-X showed safety and no serious side effects under the maximum tolerated dose of the       subject.

             2. It obtained significant effects on maintaining the body weight and quality of life of tested                    subjects.

  

3. Phase II Clinical Trial - Chronic Hepatitis B Treatment

Evaluation:A phase II adaptive design trial of BEL-X for HBeAg positive Chronic Hepatitis B

Status:File IND for US FDA and Taiwan FDA  in 1st half of  2023 

Start trial in 2023  FDA、TFDA-20221123

Target:Rapidly enhance the HBe seroconversion rate

Strength of Product:1.High Quality, High Safety (Low toxicity and low side effects)

                                   2.Global patent protectio

                                3.The Manufacturing and quality control of products followed by global regulations (PIC/S, cGMP)