At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- RCT2100 (drug), Placebo (other), RCT2100 (drug), RCT2100 (drug)
- How long the study runs
- Study runs about 33 months (dates as stated)
- About the drug or intervention
- RCT2100 — drug: RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer · Placebo — other: Placebo of similar volumes to experimental dose strengths administered via oral inhalation using nebulizer · RCT2100 — drug: RCT2100 supplied as varying dose strengths administered via oral inhalation using nebulizer for 4 weeks · RCT2100 — drug: RCT2100 supplied at a single dose strength administered via oral inhalation using nebulizer for 12 weeks · Ivacaftor — drug: ivacaftor administered orally for 6 weeks · RCT2100 — drug: RCT2100 supplied at varying dose strengths.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 60 Years
- Who
- All
- Number of participants
- 128
- Started
- 2024-02-01
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for cystic fibrosis
- • Phase2 - 128 participants
- • This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with cystic fibrosis
Where?
- • Birmingham - University Hospitals Birmingham
- • Cambridge - Royal Papworth Hospital
- • Leeds - Leeds Teaching Hospitals
- • London - King's College Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.
More detail
This is a multi-part study to assess the safety, tolerability, and biodistribution of a single ascending dose of inhaled RCT2100 administered via nebulizer to healthy participants (Part 1), the safety and tolerability of multiple-ascending doses of inhaled RCT2100 administered to participants with CF (Part 2), and the safety and tolerability of RCT2100 co-administered with ivacaftor in participants with CF (Part 3).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: All genders
What the study is looking for
- ✓Healthy, adult, male or female, 18-55 years of age, inclusive, at screening.
- ✓Body weight greater than or equal to 50 kg and body mass index (BMI) between 16-32 kg/m2, inclusive
- ✓The participant has a forced expiratory volume in one second (FEV1) of at least 80% predicted
- ✓Understands the study procedures in the agreement to take part form (ICF), and is willing and able to comply with the...
- ✓Part 1 Major
Who cannot take part
- ✗History or presence of clinically significant medical, surgical, clinical laboratory, or psychiatric condition or...
- ✗The participant has supine blood pressure (BP) \>150 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least...
- ✗The participant has abnormal clinical laboratory tests at screening, as assessed by the study-specific laboratory.
- ✗Part 2 Major Inclusion Criteria:
- ✗Confirmed diagnosis of CF
See the full criteria
Where Is This Study? (6 UK sites)
University Hospitals Birmingham
Birmingham, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
King's College Hospital
London, United Kingdom
Nottingham University Hospitals
Nottingham, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
