Delving into the Latest Updates on XKH-001 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

XKH 001, XKH-001, XKH001

Target

IL-25

Action

inhibitors

Mechanism

IL-25 inhibitors(interleukin 25 inhibitors)

Therapeutic Areas

Immune System DiseasesCongenital DisordersSkin and Musculoskeletal Diseases+ [2]

Active Indication

Moderate Atopic DermatitisSevere Atopic DermatitisAllergic asthma+ [3]

Inactive Indication

InflammationModerate asthmaSevere asthma

Originator Organization

Beijing Kanova Biopharmaceutical Co., Ltd.

Active Organization

Zhejiang Xinkanghe Biomedical Technology Co., Ltd.Beijing Kanova Biopharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

Login to view timeline

This study will be a multicenter, randomized, double-blinded, placebo-controlled clinical study. It is planned to enroll 120 adult patients with moderate-to-severe Atopic Dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical treatments are medically inadvisable.

Start Date31 Aug 2025

Sponsor / Collaborator

Zhejiang Xinkanghe Biomedical Technology Co., Ltd.

CTR20244037

/ RecruitingPhase 2

一项评估XKH001 注射液治疗中重度特应性皮炎成人患者安全性、有效性、药代动力学和药效动力学特征、免疫原性的多中心、随机、双盲、安慰剂对照、两阶段设计II 期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled, two-stage Phase II clinical trial to evaluate the safety, efficacy, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of XKH001 injection in the treatment of adult patients with moderate to severe atopic dermatitis

主要目的: 1、评估XKH001在中重度AD成人患者中的安全性； 2、评估XKH001在第16周对中重度AD成人患者的疗效。次要目的： 1、评估XKH001在第16周及其他访视点对中重度AD成人患者临床症状、体征和生活质量的疗效（生活质量仅在本试验第二阶段进行评估）； 2、评估XKH001在中重度AD成人患者中的药代动力学（PK）特征； 3、评估XKH001在中重度AD成人患者中的药效动力学（PD）特征； 4、评估XKH001在中重度AD成人患者中的免疫原性； 5、分析XKH001在中重度AD成人患者中的药物暴露与临床疗效的关系（E-R）（仅在本试验第二阶段进行分析）。探索性目的: 1、探索中重度AD成人患者皮肤组织中的生物标志物与XKH001疗效的关系。

[Translation]

Main objectives: 1. To evaluate the safety of XKH001 in adult patients with moderate to severe AD; 2. To evaluate the efficacy of XKH001 in adult patients with moderate to severe AD at week 16. Secondary objectives: 1. To evaluate the efficacy of XKH001 on clinical symptoms, signs and quality of life in adult patients with moderate to severe AD at week 16 and other visit points (quality of life is only evaluated in the second phase of this trial); 2. To evaluate the pharmacokinetic (PK) characteristics of XKH001 in adult patients with moderate to severe AD; 3. To evaluate the pharmacodynamic (PD) characteristics of XKH001 in adult patients with moderate to severe AD; 4. To evaluate the immunogenicity of XKH001 in adult patients with moderate to severe AD; 5. To analyze the relationship between drug exposure and clinical efficacy (E-R) of XKH001 in adult patients with moderate to severe AD (analyzed only in the second phase of this trial). Exploratory objectives: 1. To explore the relationship between biomarkers in skin tissue of adult patients with moderate to severe AD and the efficacy of XKH001.

Start Date17 Dec 2024

Sponsor / Collaborator

Zhejiang Xinkanghe Biomedical Technology Co., Ltd.

[+1]

NCT07070297

/ CompletedPhase 1

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

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.

Start Date26 Dec 2023

Sponsor / Collaborator

Zhejiang Xinkanghe Biomedical Technology Co., Ltd.

100 Clinical Results associated with XKH-001

Login to view more data

100 Translational Medicine associated with XKH-001

Login to view more data

100 Patents (Medical) associated with XKH-001

Login to view more data

1

Literatures (Medical) associated with XKH-001

01 Feb 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

First-in-human study on tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of XKH001, a recombinant humanized monoclonal antibody against IL-25 in healthy Chinese volunteers

Article

Author: Peng, Ran ; Sun, Tiantian ; Guo, Li ; Zhang, Hong ; Liu, Li ; Ding, Yanhua ; Liu, Yusi ; Zheng, Wenbo ; Gao, Lei ; Hu, Yue ; Wu, Dandan

BACKGROUND:

XKH001 is a recombinant humanized IgG1 monoclonal antibody against IL-25 for the treatment of type 2 inflammatory diseases. This study aimed to evaluate the tolerability, pharmacokinetics, and pharmacodynamics of XKH001 in humans for the first time.

RESEARCH DESIGN AND METHODS:

This clinical investigation adopted a randomized, double-blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) design.

RESULTS:

XKH001 was well tolerated in healthy Chinese subjects. Following repeated administration, XKH001 showed a slow absorption with a median Tmax of 4-7 days and a mean half-life (t1/2) of 22-25 days. The accumulation ratio ranged from 1.34 to 1.99. The exposure was mostly dose proportional, with a mean slope of 0.85-1.06. All subjects tested negative for ADA (except three subjects tested positive). The subjects who received 600 mg XKH001 in the MAD study showed a 78.2 ng/mL decrease in the total immunoglobulin E (IgE) level 85 days after the first administration, while the subjects who received matched placebo exhibited only an 8.6 ng/mL decrease.

CONCLUSIONS:

XKH001 showed favorable safety and pharmacokinetics profiles and a low immunogenicity in its first-in-human study. The data support its further clinical evaluation in patients with type 2 inflammatory diseases.

TRIAL REGISTRATION:

The study was registered in ClinicalTrials.gov (NCT05991661).

100 Deals associated with XKH-001

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 2	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	17 Dec 2024
Severe Atopic Dermatitis	Phase 2	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	17 Dec 2024
Asthma	Phase 2	-	Beijing Kanova Biopharmaceutical Co., Ltd.	01 Dec 2023
Allergic asthma	Phase 1	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	26 Dec 2023
Moderate asthma	Phase 1	China	Beijing Kanova Biopharmaceutical Co., Ltd.	14 Jun 2022
Severe asthma	Phase 1	China	Beijing Kanova Biopharmaceutical Co., Ltd.	14 Jun 2022
Pulmonary Disease, Chronic Obstructive	IND Approval	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	24 Jun 2025
Idiopathic Pulmonary Fibrosis	IND Approval	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	24 Jun 2025
Hypersensitivity	IND Approval	United States	Beijing Kanova Biopharmaceutical Co., Ltd.	21 Aug 2021
Inflammation	IND Approval	United States	Beijing Kanova Biopharmaceutical Co., Ltd.	21 Aug 2021

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data