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| ID | Type | Description | Link |
|---|---|---|---|
| 75N93022C00061 | Other Identifier | NIAID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | 3.5 mg Rev-56 or placebo single dose |
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| Cohort 2a | Experimental | 7 mg Rev-56 or placebo single dose |
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| Cohort 3a | Experimental | 14 mg Rev-56 or placebo single dose |
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| Cohort 4a | Experimental | 28 mg Rev-56 or placebo single dose |
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| Optional Cohort 5a | Experimental | ≤56 mg Rev-56 or placebo single dose |
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| Cohort 1b | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rev-56 for Inhalation | Combination Product | administered by inhalation via an investigational nebulizer device |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events (AEs) | 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa) | |
| 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) | 21 days (healthy participants) or 28 days (NCFB patients with P. aeruginosa) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of Rev-56 | 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) |
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Inclusion Criteria (Healthy Participants):
Inclusion Criteria (NCFB Patients with P. aeruginosa):
Exclusion Criteria (Healthy Participants):
Exclusion Criteria (NCFB Patients with P. aeruginosa):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chrissy Morgenthaler | Contact | 619-512-3538 | revagenixclinicaltrials@revagenix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Miami | Miami | Florida | 33136 | United States |
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≤28 mg Rev-56 or placebo once daily for 7 days |
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| Cohort 2b | Experimental | ≤28 mg Rev-56 or placebo twice daily for 7 days |
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| Placebo: Normal saline | Drug | administered by inhalation via an investigational nebulizer device |
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| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 28 days (NCFB patients with P. aeruginosa) |
| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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