A Phase Ib Study of RC1416 Injection (NCT06911866) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial of RC1416 injection that has already completed, what safety results — like adverse events, serious adverse events, or injection site reactions — were reported, and what might those mean for someone with my level of asthma?
2Because this was a Phase 1 study focused mainly on safety rather than proving the treatment works, how much do we actually know yet about whether RC1416 helps control moderate to severe asthma, and are there follow-up Phase 2 or 3 trials I should be aware of?
3Given that this trial is already completed, is there any way to access the findings or would you recommend I consider a currently enrolling study instead of waiting for RC1416 to progress further?
4Are there existing approved treatments for moderate to severe asthma — like biologic therapies — that might be a more proven option for me right now compared to an early-phase investigational injection like RC1416?
5Since the trial measured ECG changes and laboratory test results as safety signals, does my personal health history suggest I should be especially attentive to any of those particular risks if I were ever to consider a similar injectable treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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: