Clinical trial · Interventional
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
NCT04386343CI-TRIAL-00046776CH1701unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CH1701 for prevention and treatment of radiation burns. | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
| Safety assessment of CH1701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- PLACEBO_COMPARATOR
- label
- 50% dose level arm - Phase I
- 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
- interventionNames
- Drug: Safety assessment of CH1701
- type
- PLACEBO_COMPARATOR
- label
- 100% dose level arm - Phase I
- 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
- interventionNames
- Drug: Safety assessment of CH1701
- type
- ACTIVE_COMPARATOR
- label
- 167% dose level arm - Phase I
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
\*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
References
Publications (0)
Data not yet available
No reference posted for this study.