Clinical trials: PH1
Influenza, Pandemic
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
- Trial name
- IN-NE-rH5 (NCT05397119)
- Testing
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55.
- Trial name
- NCT06943378
- Testing
- Monoclonal antibody JST-010
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Just-Evotec Biologics
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Pulmonary Disease, Chronic Obstructive
GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)
Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule and is in development for the treatment of chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT02666287
- Testing
- BAT/FF, BAT, FF
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pulmonary Disease, Chronic Obstructive
A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects
Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- NCT02663089
- Testing
- [14C]-GSK961081 solution for IV infusion, [14C]-GSK961081 oral solution, GSK961081 dry powder for inhalation
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Anthrax
Ph1 Study of Valortim and Ciprofloxacin in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV ciprofloxacin when administered concomitantly with IV Valortim in healthy normal human subjects.
- Trial name
- NCT00964561
- Testing
- Ciprofloxacin and Valortim
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.
Methamphetamine Dependence
Ph1 Lobeline Interaction Study - 1
The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.
- Trial name
- NCT00439504
- Testing
- Lobeline
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Marijuana Dependence
Ph1 Marinol Interaction Study - Part 1 - 1
The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular…
- Trial name
- NCT00438139
- Testing
- Dronabinol
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Marijuana Dependence
Ph1 Marinol Interaction Study - Part 2 - 1
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the…
- Trial name
- NCT00490269
- Testing
- Dronabinol
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Primary Hyperoxaluria Type 1
Proteomics of Primary Hyperoxaluria Type 1
The purpose of this study is to identify unique urine protein markers of Primary Hyperoxaluria type 1 (PH1) compared to healthy controls.
- Trial name
- PH1 (NCT03067142)
- Testing
- Observational
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Primary Hyperoxaluria Type 1, Idiopathic Hypercalciuria
IDENTIFICATION OF A MULTI-ANALYTE PROFILE FOR PRIMARY HYPEROXALURIA AND COMPARISON WITH HEALTHY SIBLINGS AND IDIOPATHIC HYPERCALCIURIA
The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings.
- Trial name
- PH1 (NCT02830009)
- Testing
- Urines samples, Blood sample
- Where
- France
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Healthy Subjects
A Ph 1 Study of Epanova® in Healthy Chineses
The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population…
- Trial name
- NCT03574142
- Testing
- Epanova
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Meningococcal Infection, Group B
Phase 1 Safety and Immunogenicity of Meningococcal Vaccine
The purpose of this study is to determine whether a vaccine based on outer membrane vesicles (NOMV) from genetically detoxified group B meningococcus is safe and effective for use as a vaccine.
- Trial name
- HOPS (NCT00678652)
- Testing
- 10 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 25 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine, 50 μg Group B Meningococcal 8570 HOPS-G NOMV Vaccine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
COVID - 19
PA-001 Ph.1 Study in Healthy and Elderly Subjects
This was a double blind, randomized, placebo controlled, single and multiple IV dose study conducted in 2 parts, single ascending dose and multiple ascending doses parts.
- Trial name
- NCT07518771
- Testing
- PA-001
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- PeptiDream Inc.
Myeloproliferative Neoplasm
Role of the Circulating Procoagulants Microparticles in the Hypercoagulability of MNP Ph1-
Patients with myeloproliferative neoplasms Philadelphia chromosome negative (MPNsPh1-) such as Essential thrombocytosis (ET), Polycythemia vera (PV) and Primary Myelofibrosis (PMF) have a higher risk of arterial or deep-vein…
- Trial name
- MICROP-SMP (NCT02862366)
- Testing
- Blood sampling
- Where
- 3 sites in France
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Lille Catholic University
Healthy Volunteers
FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects
The study will comprise primarily a single-ascending dose (SAD) escalation component.
- Trial name
- NCT03970122
- Testing
- GFB-887
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Goldfinch Bio, Inc.
Healthy
Surufatinib DDI With a PPI and a CYP3A Inducer
The purpose of this is to evaluate the effect of proton pump inhibitor (rabeprazole) and the effect of a CYP3A inducer (rifampin) on the pharmacokinetics of Surufatinib.
- Trial name
- NCT04510649
- Testing
- Part A, Part B
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hutchison Medipharma Limited
Idiopathic Pulmonary Fibrosis (IPF)
TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis
This is a Phase 1, 4-part, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1058 inhaled solution.
- Trial name
- NCT04589260
- Testing
- TD-1058
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Prophylaxis Against Plasmodium Falciparum Malaria
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate, PfCP2.9 adjuvanted with Montanide ISA 720.
- Trial name
- NCT00284973
- Testing
- Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanghai Wanxing Bio-Pharmaceutical Co. Ltd.
Anthrax
Ph1 Study of Valortim and Doxycycline in Humans
The purpose of this study is to evaluate the safety and tolerability of short-term dosing of IV doxycycline when administered concomitantly with IV Valortim in normal healthy human subjects.
- Trial name
- NCT00964834
- Testing
- Doxycycline and Valortim
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PharmAthene, Inc.