Open-label Study of Inhaled RVT-1601 in Preterm Infants

NCT04007120 | Completed Phase 1 FDA Drug

• 1 other identifier: RVT1601-RMP-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity. The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.

Conditions

Respiratory Morbidities of Prematurity (RMP)

Outcome Measures

Primary Outcomes (3)

• Change in heart rate

  Assessment of heart rate (beats/min)

  Pre-dose and 15 minutes post-dose

• Change in blood pressure

  Assessment of systolic and diastolic blood pressure (mmHg)

  Pre-dose and 15 minutes post-dose

• Change in oxygenation

  Assessment of peripheral capillary oxygen saturation (SpO2)

  Pre-dose and 15 minutes post-dose

Secondary Outcomes (2)

• Peak plasma concentration (Cmax)

  30 minutes post-dose

• Total urine excretion

  8 hours post-dose

Study Arms (2)

RVT-1601 Low Dose

EXPERIMENTAL

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Drug: RVT-1601

RVT-1601 Mid Dose

EXPERIMENTAL

Inhaled RVT-1601 administered once daily over two days via eFlow nebulizer

Drug: RVT-1601

Interventions

RVT-1601 DRUG

Inhaled RVT-1601 administered once daily over two days

RVT-1601 Low Dose; RVT-1601 Mid Dose

Eligibility Criteria

• Age: 32 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants between 32 weeks 0 days and 34 weeks 6 days of PMA
• Born between 24 weeks 0 days and 29 weeks 6 days of estimated GA
• Requiring minimal or no respiratory support (i.e., supplemental oxygen with \<2 liters per minute of nasal cannula flow acceptable)
• Body weight appropriate for gestational age
• Written informed consent obtained from at least one of the parents or legal guardians

You may not qualify if:

• Requiring invasive or noninvasive respiratory support (e.g., mechanical ventilation, CPAP)
• Clinically unstable (i.e. unable to maintain SpO2 between 90-95 % , escalating respiratory support in the past 24 hours)
• Major congenital anomaly (chromosomal, renal, cardiac, hepatic, neurologic or pulmonary malformations)
• Significant cardiac disorder (i.e., pulmonary hypertension)
• History of major surgical procedure
• Any condition that would preclude receiving study drug or performing any study-related procedures
• Participation in any other investigational drug study
• History of hypersensitivity or intolerance to cromolyn sodium

Sponsors & Collaborators

• Respivant Sciences GmbH: lead
• Respivant Sciences Inc.: collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: October 1, 2019
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)