CompletedPhase 1

A Phase Ib Study of RC1416 Injection

China40 participantsStarted 2024-10-25

Plain-language summary

This is a Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RC1416 injection in patients with moderate to severe asthma.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The subject fully understands the purpose, nature, methods and potential adverse events of the trial and voluntarily signs the informed consent form (ICF);
✓. Male or female patients aged ≥18 and ≤75 years at the time of ICF signing;
✓. The subject has been diagnosed with asthma for at least one year;
✓. The subject has been treated with medium to high-dose inhaled corticosteroids (ICS) (e.g.,fluticasone propionate ≥ 250 μg daily or equivalent ICS dose) in combination with at least one additional controller medication \[such as long-acting β2 receptor agonists (LABA), long-acting anticholinergic drugs (LAMA), leukotriene receptor antagonists (LTRA), or sustained-release theophylline\] for ≥ 3 months prior to ICF signing, with a stable dosing for ≥ 1 month before randomization;
✓. ACQ-6 score \> 1.5 or ACT score \< 20 ;
✓. Pre-bronchodilator FEV1 ≤ 80% of predicted value at screening;
✓. Positive objective tests for variable airflow obstruction within one year before randomization or during the screening period (including bronchodilation test, bronchial provocation test or peak expiratory flow variability, etc.).
✓. The subject agrees to take effective contraceptive measures (as specified in the protocol) from the time of ICF signing until 6 months post-treatment.

Exclusion criteria

✕. Based on the investigator's judgment,Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may significantly impair lung function (such as atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, emphysema, etc.) ;
✕. Subjects who had required at least one systemic glucocorticoid treatment due to asthma exacerbation or other reasons, or who had been hospitalized or treated emergency department due to asthma exacerbation within one month before administration;
✕. Subjects with a history of near-fatal asthma requiring endotracheal intubation and mechanical ventilation;
✕. Subjects who are Excessive dependence on short-acting β-agonists (SABA) (\>10-12 puffs per day) , especially use more than one vial of salbutamol (or equivalent) per month;
✕. Subjects who used non-selective β-blockers within 1 month before screening until randomization;
✕. Subjects with pulmonary or other infection and oral or intravenous antibiotics or antifungal or antiviral drugs within one month before administration; Subjects have need local antibiotic or antiviral treatment within 7 days before screening;Subjects with a history of recurrent infections (≥3 times per year) and underlying diseases that predispose to infection; Subjects with a history of disseminated herpes simplex infection or recurrent (\>1 time) or disseminated herpes zoster; Subjects with a history of opportunistic infections;
✕. Subjects who underwent major surgery within 6 months prior to screening or planned major surgery during the trial.
✕. Subjects who have suffered form malignancy within 5 years,except:

What they're measuring

Timeframe: up to 141 days

SAE

Timeframe: up to 141 days

Vital Signs

Timeframe: up to 141 days

Laboratory Tests

Timeframe: up to 141 days

ECG

Timeframe: up to 141 days

Injection Site Reaction

Timeframe: up to 85 days

Trial details

NCT IDNCT06911866

SponsorNanjing RegeneCore Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-25

View on ClinicalTrials.gov More Moderate to Severe Asthma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The subject fully understands the purpose, nature, methods and potential adverse events of the trial and voluntarily signs the informed consent form (ICF);
✓. Male or female patients aged ≥18 and ≤75 years at the time of ICF signing;
✓. The subject has been diagnosed with asthma for at least one year;
✓. The subject has been treated with medium to high-dose inhaled corticosteroids (ICS) (e.g.,fluticasone propionate ≥ 250 μg daily or equivalent ICS dose) in combination with at least one additional controller medication \[such as long-acting β2 receptor agonists (LABA), long-acting anticholinergic drugs (LAMA), leukotriene receptor antagonists (LTRA), or sustained-release theophylline\] for ≥ 3 months prior to ICF signing, with a stable dosing for ≥ 1 month before randomization;
✓. ACQ-6 score \> 1.5 or ACT score \< 20 ;
✓. Pre-bronchodilator FEV1 ≤ 80% of predicted value at screening;
✓. Positive objective tests for variable airflow obstruction within one year before randomization or during the screening period (including bronchodilation test, bronchial provocation test or peak expiratory flow variability, etc.).
✓. The subject agrees to take effective contraceptive measures (as specified in the protocol) from the time of ICF signing until 6 months post-treatment.

Exclusion criteria

✕. Based on the investigator's judgment,Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may significantly impair lung function (such as atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, bronchiectasis, emphysema, etc.) ;
✕. Subjects who had required at least one systemic glucocorticoid treatment due to asthma exacerbation or other reasons, or who had been hospitalized or treated emergency department due to asthma exacerbation within one month before administration;
✕. Subjects with a history of near-fatal asthma requiring endotracheal intubation and mechanical ventilation;
✕. Subjects who are Excessive dependence on short-acting β-agonists (SABA) (\>10-12 puffs per day) , especially use more than one vial of salbutamol (or equivalent) per month;
✕. Subjects who used non-selective β-blockers within 1 month before screening until randomization;
✕. Subjects with pulmonary or other infection and oral or intravenous antibiotics or antifungal or antiviral drugs within one month before administration; Subjects have need local antibiotic or antiviral treatment within 7 days before screening;Subjects with a history of recurrent infections (≥3 times per year) and underlying diseases that predispose to infection; Subjects with a history of disseminated herpes simplex infection or recurrent (\>1 time) or disseminated herpes zoster; Subjects with a history of opportunistic infections;
✕. Subjects who underwent major surgery within 6 months prior to screening or planned major surgery during the trial.
✕. Subjects who have suffered form malignancy within 5 years,except: