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Bridging Study of XKH001 in Healthy Adult Caucasian Participants

NCT07757659 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-08-11

No results posted yet for this study

Summary

This is a Phase Id, randomised, double-blind, placebo-controlled, multiple-dose, bridging study conducted at a single Phase I clinical research unit in Australia. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of XKH001 following repeated subcutaneous administration in healthy adult Caucasian participants, and to provide an ethnic-bridging pharmacokinetic comparison with the prior Phase I dataset in Chinese participants, required for XKH001's global development programme.

Conditions

  • Healthy Adult

Interventions

DRUG

XKH001 Injection

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.

DRUG

XKH001 Placebo Injection

Placebo；

Sponsors & Collaborators

  • Zhejiang Kanova Biopharmaceutical Co., LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-04-01
Completion
2027-08-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757659 on ClinicalTrials.gov