CH1701 for Prevention and Treatment of Radiation Burns

A Combined Phase I&II, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety for Prevention and Treatment of Radiation Therapy Burn of CH1701

A combined Phase I&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701

*Phase I:

Inclusion Criteria:

• Healthy volunteers, aged 18 and older at the time of enrollment
• Voluntarily participate in the study by signing a consent form to participate in the study
• Ability to adhere to treatment according to researchers' assessment

Exclusion Criteria:

• Subjects with other acute or chronic diseases need to be treated

• It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher

  • Phase II:

Inclusion Criteria:

• Female patient, aged 18 to 60 years old
• Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
• Treatment can be started within 3 days of signing the consent to participate in the study
• Agree to voluntarily sign the consent form to participate in the study

Exclusion Criteria:

• The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
• The patient had radiation therapy before the breast area
• History of connective tissue disorders
• The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
• Participate in other clinical trial studies within 1 month before joining this study