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A Randomized, Phase Ib, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SKB575 (HBM7575) in Participants With Asthma

ConditionAsthma (Diagnosis)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The participant is able to understand and comply with the requirements of this study, and voluntarily signs the informed consent form.

Aged between 18 and 70 years inclusive at the time of signing the informed consent form, with no restriction on gender.

Body Mass Index (BMI) shall be ≥ 18.0 kg/m² and ≤ 32.0 kg/m².

Diagnosis of asthma consistent with the Global Initiative for Asthma (GINA) 2025 diagnostic criteria.

Disqualifiers

Within 3 months prior to randomization, the participant experienced an acute asthma exacerbation requiring continuous systemic corticosteroid therapy for ≥3 consecutive days, or presented to the emergency department or was hospitalized due to asthma with administration of systemic corticosteroids (calculated from the completion date of treatment for the asthma exacerbation).

Known hypersensitivity to the investigational product or its excipients, or a history of allergic reactions to any biological products.

Concomitant clinically significant pulmonary diseases, including but not limited to pulmonary infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, pulmonary vascular disease, pulmonary neoplasm, or any other diseases affecting pulmonary function other than asthma.

Concomitant diseases that may impair pulmonary function, including but not limited to clinically significant pleural disorders, mediastinal diseases, diaphragmatic lesions, myasthenia, thoracic deformities, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKB575

    Drug

    Subcutaneous

  • Placebo

    Drug

    Subcutaneous

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: SKB575Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of participants with adverse events (AEs), serious adverse events (SAE)

Time frame
From baseline to week 32
2

Changes of fractional exhaled nitric oxide (FeNO) compared with baseline at week 8

Time frame
Week 8

Secondary outcomes

1

Change from baseline in FeNO

Time frame
From baseline to week 32
2

Change from baseline in pre-bronchodilator (BD) FEV1

Time frame
From baseline to week 32
3

Change from baseline in post-BD FEV1

Time frame
From baseline to week 32
4

Change from baseline in ACQ-5 score

ACQ-5 is Asthma control questionnaire assessing symptoms, has a scoring range of 0 to 6 points. Lower score shows better asthma control.

Time frame
From baseline to week 32

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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