A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
27 juli 2026 uppdaterad av: Revagenix, Inc.
A Sequential, Phase 1a/1b, Double-blind, 2-part Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Rev-56 for Inhalation Compared With Placebo in Healthy Adult Participants and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic Pseudomonas Aeruginosa
This is a Phase 1a/1b study to test the safety, tolerability, microbiological response, and pharmacokinetics of inhaled Rev-56 compared to placebo in adult healthy participants and non-cystic fibrosis bronchiectasis (NCFB) patients with P. aeruginosa, respectively.
Phase 1a (Part A) will evaluate single doses of inhaled Rev-56 in adult healthy participants and includes up to 5 cohorts. Eligible participants will be randomized to active treatment or placebo in a 3:1 randomization scheme.
Phase 1b (Part B) will evaluate the safety, tolerability, microbiological response, and pharmacokinetics of multiple doses of inhaled Rev-56 in NCFB patients with P. aeruginosa and includes 2 cohorts evaluating once daily dosing and twice daily dosing, respectively. Eligible participants will be randomized to active treatment or placebo in a 2:1 randomization scheme.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
64
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Chrissy Morgenthaler
- Telefonnummer: 619-512-3538
- E-post: revagenixclinicaltrials@revagenix.com
Studieorter
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- Rekrytering
- Syneos Health Miami
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria (Healthy Participants):
- Healthy male and female participants aged 18 to 55 years, inclusive
- Body mass index > 18 to ≤ 32 kg/m^2
- Forced expiratory volume in 1 second (FEV1) ≥ 80%
- Creatinine clearance ≥ 90 mL/min
- Normal laboratory values and physical exam at screening, or Grade 1 abnormalities that are not clinically significant
Inclusion Criteria (NCFB Patients with P. aeruginosa):
- Male and female NCFB patients aged 18 to 80 years, inclusive
- Bronchiectasis confirmed by prior computerized tomography (CT) scan
- Chronic P. aeruginosa infection (≥ 2 positive cultures within prior 12 months)
- Screening sputum culture positive for P. aeruginosa at ≥ 10^4 CFU/mL
- FEV1 ≥ 50% (post bronchodilator)
Exclusion Criteria (Healthy Participants):
- Clinically significant medical history
- Acute illness within 4 weeks of screening
- Current smoker or nicotine user
- History of alcohol abuse (within prior 12 months) or drug/chemical abuse
Exclusion Criteria (NCFB Patients with P. aeruginosa):
- Primary asthma, chronic obstructive pulmonary disease (COPD), or cystic fibrosis (CF)
- More than 2 pulmonary exacerbations requiring IV antibiotics within 12 months prior to screening
- Receipt of antibiotics (excluding macrolides) within 30 days prior to screening
- Clinically significant hemoptysis requiring intervention within 30 days prior to screening
- Receiving anti-infective treatment for concurrent nontuberculosis mycobacteria (NTM) or fungal infection
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort 1a
3.5 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Cohort 2a
7 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Cohort 3a
14 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Cohort 4a
28 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Optional Cohort 5a
≤56 mg Rev-56 or placebo single dose
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Cohort 1b
≤28 mg Rev-56 or placebo once daily for 7 days
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administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
|
Experimentell: Cohort 2b
≤28 mg Rev-56 or placebo twice daily for 7 days
|
administered by inhalation via an investigational nebulizer device
administered by inhalation via an investigational nebulizer device
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Incidence and severity of treatment-emergent adverse events (AEs)
Tidsram: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
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21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
|
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Number of participants with clinically significant abnormalities in lab parameters, vital signs, respiratory function, and ECG parameters graded by FDA Toxicity Grading Scale (for healthy participants) and DAIDS Toxicity Tables (for NCFB patients)
Tidsram: 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
|
21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum observed concentration (Cmax) of Rev-56
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Time to Cmax of Rev-56 (Tmax)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Area under the curve from time 0 to last measurable concentration (AUC0-last)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Area under the curve from time 0 to 24 hours after completion of dosing (AUC0-24)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Area under the curve from time 0 to infinity (AUC0-inf)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Clearance of Rev-56 (CL/F)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Half-life of Rev-56 (t½)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Volume of distribution of Rev-56 (Vz/F)
Tidsram: Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
Healthy Participants: predose, and 5 min, 15 min, 45 min, 90 min, 3h, 6h, 12h, 24h and 48h post inhalation; NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Minimum observed concentration of Rev-56 (Cmin)
Tidsram: NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
NCFB Patients: pre-dose, and 5 min, 15 min, 45 min, 90 min, 3h, 8h, 12h (Cohort 2b only) and 24h (Cohort 1b only) after completion of inhalation
|
|
Mean P. aeruginosa burden (CFU/mL) in sputum culture compared to baseline
Tidsram: 28 days (NCFB patients with P. aeruginosa)
|
28 days (NCFB patients with P. aeruginosa)
|
Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
13 juli 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
2 juli 2026
Först inskickad som uppfyllde QC-kriterierna
13 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Rev-56-001
- 75N93022C00061 (Annan identifierare: NIAID)
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