CH1701 for Prevention and Treatment of Radiation Burns

NCT04386343 | Unknown Phase 1

• 1 other identifier: CH1701
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (7)

50% dose level arm - Phase I

PLACEBO COMPARATOR

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

100% dose level arm - Phase I

PLACEBO COMPARATOR

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

167% dose level arm - Phase I

ACTIVE COMPARATOR

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

Placebo arm - Phase II

PLACEBO COMPARATOR

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

Drug: Placebos

50% dose level arm - Phase II

PLACEBO COMPARATOR

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.

100% dose level arm - Phase II

PLACEBO COMPARATOR

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.

167% dose level arm - Phase II

PLACEBO COMPARATOR

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.

Interventions

CH1701 for prevention and treatment of radiation burns. DRUG

Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.

100% dose level arm - Phase II; 167% dose level arm - Phase II; 50% dose level arm - Phase II

Safety assessment of CH1701 DRUG

Safety assessment of CH1701 after 14 days of use on volunteers

100% dose level arm - Phase I; 167% dose level arm - Phase I; 50% dose level arm - Phase I

Placebos DRUG

The placebo was used on patients as a control for the doses of CH1701

Placebo arm - Phase II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• Vietlife Healthcare Corporation: lead
• Vietnam National Cancer Hospital: collaborator

Study Sites (1)

Vietlife Healthcare Corporation

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigator are blinded to the treatment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 25, 2019
• First Posted: May 13, 2020
• Study Start: July 5, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-05

Locations

VN (1)