Clinical trials: Respiratory Disease of A Newborn
- Condition Respiratory Disease of A Newborn
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Cystic Fibrosis
Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with…
- Trial name
- NCT07349394
- Testing
- VNZ/TEZ/D-IVA, Rosuvastatin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Respiratory Syncytial Virus
A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age
The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a…
- Trial name
- NCT01995175
- Testing
- Nasal swab sampling, Blood sampling, Diary cards
- Where
- 23 sites in United States, Argentina and 6 more
- Volunteers
- 2,409 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alpha-1 Antitrypsin Deficiency (AATD)
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
This study is the first study in the RestorAATion clinical program. The purpose of this first-in human (FIH), double-blind, randomized, placebo-controlled, single ascending dose (SAD) and multiple-dose Phase 1 study is to assess…
- Trial name
- RestorAATion-1 (NCT06186492)
- Testing
- WVE-006
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Wave Life Sciences USA, Inc.
Cystic Fibrosis
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and…
- Trial name
- NCT04926701
- Testing
- ETD001 single dose, ETD001 multiple twice daily doses, ETD001 multiple once daily doses
- Where
- United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Enterprise Therapeutics Ltd
Cystic Fibrosis
A Phase 1 Study to Evaluate the Relative Bioavailability of a VX-828 Tablet Formulation
The purpose of this study is to evaluate the relative bioavailability of a VX-828 tablet formulation compared to a suspension and evaluate its safety and tolerability.
- Trial name
- NCT06861413
- Testing
- VX-828
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Bronchopulmonary Dysplasia
129Xe MRI in Pediatric Population With BPD
Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder.
- Trial name
- NCT04035629
- Testing
- MagniXene, hyperpolarized 129Xe MRI
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Xemed LLC
Cystic Fibrosis (CF)
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
This study will be performed to assess the safety, tolerability and PK of escalating inhaled AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive days in healthy subjects.
- Trial name
- NCT02605590
- Testing
- AIR DNase
- Where
- Israel
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Protalix
Cystic Fibrosis
An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
- Trial name
- NCT05867147
- Testing
- Vanzacaftor, Moxifloxacin
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Allergic Asthma, Atopic Dermatitis
A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
Phase 1 study to evaluate the safety of MEDI4212.
- Conditions
- Allergic Asthma, Atopic Dermatitis, Allergic Rhinitis, Healthy Volunteers
- Trial name
- NCT01544348
- Testing
- Omalizumab, MEDI4212 5 mg Subcutaneous, MEDI4212 15 mg Subcutaneous
- Where
- 7 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Alpha 1-Antitrypsin Deficiency
Study of ARO-AAT in Normal Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.
- Trial name
- NCT03362242
- Testing
- ARO-AAT Injection, Sterile Normal Saline (0.9% NaCl)
- Where
- New Zealand
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Cystic Fibrosis
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)
The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.
- Trial name
- NCT06299709
- Testing
- VNZ/TEZ/D-IVA
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential…
- Trial name
- NCT01768663
- Testing
- Lumacaftor, Ivacaftor, Ciprofloxacin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Mitochondrial Diseases, Mitochondrial Respiratory Chain Deficiencies
A Phase Ia/Ib, SAD and MAD Study of of KL1333 in Healthy Subjects and Patients With Primary Mitochondrial Disease
This will be a double blind, randomised, placebo controlled, single and multiple oral dose study conducted in 3 parts: Part A, Part B and Part C.
- Conditions
- Mitochondrial Diseases, Mitochondrial Respiratory Chain Deficiencies, MELAS Syndrome, Mitochondrial Myopathies
- Trial name
- NCT03888716
- Testing
- KL1333
- Where
- 2 sites in United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Abliva AB
Asthma, Atopic Dermatitis
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and…
- Conditions
- Asthma, Atopic Dermatitis, Healthy
- Trial name
- NCT02345928
- Testing
- Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2 (Atopic Dermatitis): CNTO 7160
- Where
- 7 sites in Belgium, Germany
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Cystic Fibrosis
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
Evaluate the safety and tolerability of VX-659 in healthy subjects
- Trial name
- NCT03029455
- Testing
- VX-659, Tezacaftor, Ivacaftor
- Where
- 10 sites in United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Chronic Obstructive Pulmonary Disease
A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects
This is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether GS-5737 in 2.8% saline accelerates mucociliary clearance (MCC) in healthy subjects, compared to vehicle of 2.8% saline alone.
- Trial name
- NCT01793649
- Testing
- GS-5737
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Asthma
A Study to Evaluate the Safety, Tolerability and Absorption to the Blood After Administration of Single and Multiple Doses of AZD8154 in Healthy Participants.
This study is a Phase 1, first in human (FiH) study, consisting of 3 parts (Part 1, Part 2, and Part 3) in healthy male and female participants of non-childbearing potential, performed at a single study center.
- Trial name
- NCT03436316
- Testing
- AZD8154
- Where
- Germany
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Cystic Fibrosis
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in…
- Trial name
- NCT00800579
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy Volunteer, Cystic Fibrosis
Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis
This trial will consist of two parts: Part 1 and Part 2. Part 1 will enroll adult healthy volunteers (HV) into four treatment groups.
- Trial name
- NCT03140527
- Testing
- PTI-801, PTI-808
- Where
- 38 sites in United States, Canada and 3 more
- Volunteers
- 171 people, healthy volunteers welcome
- Sponsor
- Proteostasis Therapeutics, Inc.
Healthy Subjects, Cystic Fibrosis
A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis
This Phase 1/2a study is a double-blinded (subject and Investigator), randomized, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple…
- Trial name
- NCT03647228
- Testing
- IONIS-ENaCRx
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.