NCT07070297

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

A Single-Arm Study to Evaluate the Effect on Airway Hyperresponsiveness, Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics Characteristics of XKH001 Injection in Patients With Allergic Asthma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The screening period will not be more than 28 days (i.e., 4 weeks). The treatment period will be 12 weeks, and the follow-up period will be 12 weeks. All recruited patients with allergic asthma will undergo various screening procedures within 28 days prior to the first dose, and those who pass the screening will be sequentially enrolled. Patients who are enrolled in the study will be admitted to the study site on the day before each scheduled dose (D-1, D28, and D56) to complete the necessary pre-dose safety assessments and receive XKH001 subcutaneous (SC) injections on D1, D29, and D57. The patient will undergo regular safety assessment procedures (AE/SAE, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), etc.), FeNO, pulmonary function tests (FEV1 PD20 Mch), sputum induction, and other blood sample collections (PK, PD, and ADA) during the treatment period (D1-D85) and the subsequent 12-week follow-up period (\~D169). Visits and procedures at screening, treatment, and follow-up are detailed in the Schedule of Assessment. If a subject discontinues treatment prematurely, the "Early Withdrawal" visit and all procedures will be performed, the same as D169. If asthmatic patients test positive for seasonal allergens (such as pollen), they should avoid the allergy season when enrolling in the study.

Conditions

• Asthma Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-10-10
• Completion: 2024-12-20
• First posted: 2025-07-17
• Last updated: 2025-07-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study