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 DermatitisAsthma+ [3]

Inactive Indication

InflammationModerate asthmaSevere asthma

Originator Organization

Beijing Kanova Biopharmaceutical Co., Ltd.

Active Organization

Beijing Kanova Biopharmaceutical Co., Ltd.

Zhejiang Xinkanghe Biomedical Technology Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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[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]

CTR20233355

/ CompletedPhase 1

一项评估XKH001注射液在过敏性哮喘患者多次给药后对气道高反应性的影响、安全性、免疫原性、药代动力学和药效动力学特征的单臂Ic期临床试验

[Translation] A single-arm Phase Ic clinical trial to evaluate the effects of XKH001 injection on airway hyperresponsiveness, safety, immunogenicity, pharmacokinetic and pharmacodynamic characteristics after multiple doses in patients with allergic asthma

主要试验目的：评估XKH001注射液在过敏性哮喘患者多次给药后对气道高反应性的影响和安全性。次要试验目的：评估XKH001注射液在过敏性哮喘患者多次给药的免疫原性、PK（药代动力学）特征和PD（药效动力学）特征。

[Translation]

Primary study objective: To evaluate the effect and safety of XKH001 injection on airway hyperresponsiveness after multiple administration in patients with allergic asthma. Secondary study objective: To evaluate the immunogenicity, PK (pharmacokinetic) characteristics and PD (pharmacodynamic) characteristics of XKH001 injection in patients with allergic asthma after multiple administration.

Start Date01 Dec 2023

Sponsor / Collaborator

Beijing Kanova Biopharmaceutical Co., Ltd.

NCT05991661

/ Not yet recruitingPhase 1/2

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XKH001 Injection in Healthy Subjects

This study is a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical study. The primary objective is to evaluate the safety, tolerability, and PK of multiple SC doses of XKH001 in healthy subjects.

Start Date01 Dec 2023

Sponsor / Collaborator

Beijing Kanova Biopharmaceutical Co., Ltd.

100 Clinical Results associated with XKH-001

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100 Translational Medicine associated with XKH-001

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100 Patents (Medical) associated with XKH-001

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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

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R&D Status

10 top R&D records.

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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	Beijing Kanova Biopharmaceutical Co., Ltd.	01 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
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
Idiopathic Pulmonary Fibrosis	IND Application	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	01 May 2025
Pulmonary Disease, Chronic Obstructive	IND Application	China	Zhejiang Xinkanghe Biomedical Technology Co., Ltd.	01 May 2025

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