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A Single-Arm Phase Ic Clinical Study of XKH001 Injection in Patients With Allergic Asthma After Multiple Doses

NCT07070297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-17

No results posted yet for this study

Summary

This study is a single-arm, open-label clinical study. A total of 12 patients with allergic asthma are planned to be enrolled to receive XKH001 600 mg Q4W administration for the assessment of the safety, immunogenicity, PK, and PD characteristics of multiple doses.

Conditions

  • Asthma Patients

Interventions

DRUG

XKH001 Injection

Dosage: 600 mg Q4W (D1, D29 and D57) Method of administration: the drug will be administered by SC injection in an area 3 cm away from and within 5 cm around the umbilicus of the abdomen. Sites with skin damage, inflammation, ulceration, rash and scar should be avoided. Subjects should be closely observed for reactions within 4 h after dosing.

Sponsors & Collaborators

  • Zhejiang Kanova Biopharmaceutical Co., LTD

    lead INDUSTRY

Principal Investigators

  • Wen Li, Dr · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-26
Primary Completion
2024-10-10
Completion
2024-12-20
FDA Drug
Yes

Countries

  • China

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 NCT07070297 on ClinicalTrials.gov