CH1701 for Prevention and Treatment of Radiation Burns

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: CH1701 for prevention and treatment of radiation burns.
* Drug: Safety assessment of CH1701
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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*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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase I: Three dose level - 50%, 100% and 167% of the expected dose level Phase II: Four dose level - 0% (Placebo), 50%, 100% and 167% of the expected dose level
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 50% dose level arm - Phase I<br>4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side | Drug: Safety assessment of CH1701<br>* Safety assessment of CH1701 after 14 days of use on volunteers<br>|
| Placebo Comparator: 100% dose level arm - Phase I<br>4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side | Drug: Safety assessment of CH1701<br>* Safety assessment of CH1701 after 14 days of use on volunteers<br>|
| Active Comparator: 167% dose level arm - Phase I<br>4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side | Drug: Safety assessment of CH1701<br>* Safety assessment of CH1701 after 14 days of use on volunteers<br>|
| Placebo Comparator: Placebo arm - Phase II<br>20 Breast cancer patients will use Placebo in the radiation affected area right after radiation | Drug: Placebos<br>* The placebo was used on patients as a control for the doses of CH1701<br>|
| Placebo Comparator: 50% dose level arm - Phase II<br>20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation | Drug: CH1701 for prevention and treatment of radiation burns.<br>* Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.<br>|
| Placebo Comparator: 100% dose level arm - Phase II<br>20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation | Drug: CH1701 for prevention and treatment of radiation burns.<br>* Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.<br>|
| Placebo Comparator: 167% dose level arm - Phase II<br>20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation | Drug: CH1701 for prevention and treatment of radiation burns.<br>* Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects by skin biopsy | Skin biopsy after 14 days of topical application, compared with healthy skin | 14 days | 
| Degree of burns according to CTCAE 4.03 atlas | Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns | 63 days |