Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection

Sponsor
Zhejiang Kanova Biopharmaceutical Co., LTD
Study ID
NCT07519499
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • XKH001Injection — DRUG
    XKH001, developed by Zhejiang Kanova Biopharmaceutical Co., Ltd., is a recombinant anti-IL-25 humanized IgG1 monoclonal antibody (mAb) composed of two identical light chains and two identical heavy chains linked by disulfide bonds. Each light chain consists of 215 amino acids, and each heavy chain consists of 455 amino acids, for a total of 1340 amino acids. XKH001 has a total of 16 pairs of disulfide bonds, including 4 pairs of intra-light chain disulfide bonds, 8 pairs of intra-heavy chain disulfide bonds, 2 pairs of light-heavy interchain disulfide bonds, and 2 pairs of heavy-heavy interchain disulfide bonds. XKH001 has an N-glycosylation site at N305 of the heavy chain, with G0F oligosaccharide being the major form of N-glycosylation.
  • Placebo — DRUG
    Placebo

Study Details

This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.

Key Dates

First listed
Apr 9, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Dec 1, 2027
Completion
Feb 1, 2028

Study Design

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

Arms

  • Active Comparator: XKH001 300mg
    XKH001 Injection 300 mg once every four weeks \[Q4W\]
  • Active Comparator: XKH001 600mg
    XKH001 Injection 600 mg once every four weeks \[Q4W\]
  • Placebo Comparator: Placebo group
    Placebo once every four weeks \[Q4W\]

Primary Outcome Measure

Primary Outcome1 [ Time Frame: Week 36 ]

Central Contacts

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