Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Study ID
NCT06895499
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • HB0043 — DRUG
    Low dose
  • HB0043 — DRUG
    Medium dose
  • HB0043 — DRUG
    High dose

Study Details

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

Key Dates

First listed
Mar 26, 2025
Start date
Mar 19, 2025
Status verified
Jan 2026
Primary completion
Jan 30, 2026
Completion
Mar 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HB0043: Low dose
    Participants assigned to arm 1 will receive a low dose of HB0043 via intravenous infusion every two weeks starting from week 0. The dose of HB0043 will adjusted to high dose at weeks 10, and the frequency remains Q2W. The frequency will adjusted to Q4W from weeks16, the last administration is weeks 20.
  • Experimental: HB0043: Medium dose
    Participants assigned to Arm 2 will receive a medium dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.
  • Experimental: HB0043: High dose
    Participants assigned to Arm 3 will receive a high dose of HB0043 via intravenous infusion every two weeks, commencing at week 0, and then at weeks 16 and 20.

Primary Outcome Measure

Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS [ Time Frame: From randomization to end of study, assessed up to 24 weeks. ]

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