A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants

Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Study ID
NCT07488065
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • SKB575 Injection/SKB575 Placebo — DRUG
    Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Study Details

This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.

Key Dates

First listed
Mar 23, 2026
Start date
Mar 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A1
  • Experimental: A2
  • Experimental: A3
  • Experimental: A4
  • Experimental: A5
  • Experimental: B1
  • Experimental: B2
  • Experimental: B3

Primary Outcome Measure

Number of participants with adverse events (AEs) /TEAEs [ Time Frame: From Baseline to Day 225 ]

Central Contacts

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Atopic dermatitis / eczema trialsDermatology trialsRheumatology trialsAutoimmune disease trials

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