Clinical Study of CFH Protein Via Ice Microneedles for Radiation-Induced Skin Fibrosis

Sponsor
West China Hospital
Study ID
NCT07567235
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CFH Protein-loaded Ice Microneedles (0.5 mg) — BIOLOGICAL
    Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 0.5 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
  • CFH Protein-loaded Ice Microneedles (1.0 mg) — BIOLOGICAL
    Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 1.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
  • CFH Protein-loaded Ice Microneedles (2.0 mg) — BIOLOGICAL
    Recombinant human CFH protein delivered intradermally via ice microneedle patches at a total dose of 2.0 mg per administration, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.

Study Details

This phase I, open-label, single-arm, non-randomized clinical trial uses a "3+3" dose-escalation design to evaluate the safety, tolerability, and preliminary efficacy of intradermal delivery of complement factor H (CFH) fragment (human, 860-1231aa) via ice microneedles for the prevention of radiation-induced skin fibrosis in patients with head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) receiving postoperative adjuvant radiotherapy. The main questions are: 1. The safety profile, including dose-limiting toxicities (DLTs) within 28 days after the first dose, adverse events, and tolerability. 2.Preliminary efficacy, assessed by changes in irradiated skin thickness, palpation of fibrotic area, CTCAE grade ≤2 fibrosis rate, and quality of life. Participants receive CFH ice microneedle patches twice weekly for a total of 8 doses (starting at 0.5 mg, escalating to 1.0 mg and 2.0 mg), applied to the skin area to be irradiated.

Key Dates

First listed
May 5, 2026
Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Dose Level 1: CFH Protein 0.5 mg via Ice Microneedles
    Participants receive intradermal delivery of CFH protein at a total dose of 0.5 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
  • Experimental: Dose Level 2: CFH Protein 1.0 mg via Ice Microneedles
    Participants receive intradermal delivery of CFH protein at a total dose of 1.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.
  • Experimental: Dose Level 3: CFH Protein 2.0 mg via Ice Microneedles
    Participants receive intradermal delivery of CFH protein at a total dose of 2.0 mg per administration via ice microneedle patches, twice weekly for a total of 8 doses, starting on the first day of radiotherapy.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: First 28 days after the first study drug administration ]

Central Contacts

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