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NCT05382910 | Recruiting | Asthma


A Study of MG-K10 in Subjects With Asthma
Sponsor:

Shanghai Mabgeek Biotech.Co.Ltd

Brief Summary:

This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.

Condition or disease

Asthma

Intervention/treatment

MG-K10

Placebo

Phase

Phase 1

Phase 2

Detailed Description:

The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.

Study Type : Interventional
Estimated Enrollment : 180 participants
Masking: Quadruple
Primary Purpose: Treatment
Official Title: Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : December 20, 2023
Estimated Study Completion Date : June 20, 2024
Arm Intervention/treatment

Experimental: MG-K10 Q2W

Received MG-K10 300 mg subcutaneous injection every 2 weeks

Drug: MG-K10

Experimental: MG-K10 Q4W

Received MG-K10 300 mg subcutaneous injection every 4 weeks

Drug: MG-K10

Placebo Comparator: Placebo

The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.

Drug: Placebo

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year;
  • 1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value;
  • Must have experienced at least one severe acute asthma attack within 12 months outbreak event.
  • Positive bronchodilator test
  • Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment
Exclusion Criteria
  • Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function
  • Subjects with malignant tumor within 5 years
  • Received biologics with the same therapeutic purpose within 6 months prior to screening,
  • Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;

A Study of MG-K10 in Subjects With Asthma

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A Study of MG-K10 in Subjects With Asthma

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Locations


Recruiting

China, Guangdong

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510000

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