Clinical Trials

1.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 

Trial site:National Taiwan University Hospital  

National Cheng Kung University Hospital  

Period:2017.05-2020.04

Results:

1.BEL-X showed excellent safety with no serious side effects under the maximum tolerated dose.

2.It obtained significant effects on maintaining the body weight and quality of life of participated 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 Treatment

Status:File IND for Both US FDA and Taiwan FDA in first half of 2023, and start trial after obtaining IND approvals 

Goal: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)