CH1701 for Prevention and Treatment of Radiation Burns

Vietlife Healthcare

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: CH1701 for prevention and treatment of radiation burns.; Drug: Safety assessment of CH1701; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04386343

CH1701

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

*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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 7 patient groups, including a placebo group

50% dose level arm - Phase I

Placebo Comparator group

Description:

4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side

Treatment:

Drug: Safety assessment of CH1701

100% dose level arm - Phase I

Placebo Comparator group

Description:

4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side

Treatment:

Drug: Safety assessment of CH1701

167% dose level arm - Phase I

Active Comparator group

Description:

4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side

Treatment:

Drug: Safety assessment of CH1701

Placebo arm - Phase II

Placebo Comparator group

Description:

20 Breast cancer patients will use Placebo in the radiation affected area right after radiation

Treatment:

Drug: Placebos

50% dose level arm - Phase II

Placebo Comparator group

Description:

20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation

Treatment:

Drug: CH1701 for prevention and treatment of radiation burns.

100% dose level arm - Phase II

Placebo Comparator group

Description:

20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation

Treatment:

Drug: CH1701 for prevention and treatment of radiation burns.

167% dose level arm - Phase II

Placebo Comparator group

Description:

20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation

Treatment:

Drug: CH1701 for prevention and treatment of radiation burns.