Clinical trials: Proof of Concept
Healthy Volunteer Study
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
The goal of this clinical study is to evaluate safety of Xenon gas inhalation in healthy volunteers. This first phase safety clinical study is part of evaluation of the xenon gas inhalation as a therapy for neurodegenerative…
- Trial name
- NCT06945614
- Testing
- Xenon gas inhalation
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- General Biophysics LLC
Malaria
Proof-of-Concept Study of MSP3-LSP Vaccine to Protect Against Malaria in Africa
Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days…
- Trial name
- MSP3-POC (NCT01341704)
- Testing
- MSP3-LSP/AlOH, Verorab Vaccine, 0.9% NaCl/Normal Saline
- Where
- Mali
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Vac4All
Myelodysplastic Syndromes
Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
The main purpose of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent participants with low or intermediate-1 risk Myelodysplastic…
- Trial name
- NCT03011034
- Testing
- Talacotuzumab, Daratumumab
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Covid19
To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.
A two arm open label multi-centered randomized interventional trial is proposed to assess aspects of safety and efficacy of Nuvastatic™ (Serial No: C5OSEW5050ESA) .
- Trial name
- NCT04542447
- Testing
- Nuvastatic
- Where
- India
- Volunteers
- 10 people
- Sponsor
- Natureceuticals Sdn Bhd
Healthy
A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females.
- Trial name
- NCT03535571
- Testing
- Salmon Protein Hydrolysate
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Hofseth Biocare ASA
Polymyositis
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
This study assessed the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with polymyositis who had shown inadequate response to corticosteroids…
- Trial name
- NCT01801917
- Testing
- BAF312
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19, Acute Respiratory Distress Syndrome (ARDS)
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administered 3 times daily (TID)…
- Trial name
- RESCUE (NCT04511650)
- Testing
- Razuprotafib Subcutaneous Solution
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- EyePoint Pharmaceuticals, Inc.
Heart Failure With Reduced Ejection Fraction
Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients
Cognitive impairment (CI) is highly prevalent in patients with heart failure with reduced ejection fraction (HFrEF), which has significant implications for disease management, quality of life and clinical outcomes.
- Trial name
- LYRIC-HF (NCT07695090)
- Testing
- Lumacaftor 200 MG
- Where
- 2 sites in Canada
- Volunteers
- 60 people
- Sponsor
- Qanatpharma AG
Acute Lung Injury
Study in Intensive Care Patients to Investigate the Clinical Effect of Repetitive Orally Inhaled Doses of AP301 on Alveolar Liquid Clearance in Acute Lung Injury
The purpose of this study is to assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI (acute lung injury) patients with the purpose to assess the treatment associated changes of extravascular lung water…
- Trial name
- NCT01627613
- Testing
- AP301, Saline solution
- Where
- Austria
- Volunteers
- 40 people
- Sponsor
- Apeptico Forschung und Entwicklung GmbH
Pneumonia, Ventilator-Associated, Pseudomonas Infections
Azithromycin as a Quorum-Sensing Inhibitor for the Prevention of Pseudomonas Aeruginosa Ventilator-Associated Pneumonia
The purpose of this study is to assess the clinical efficacy of azithromycin, used as a quorum-sensing blocker, when compared to placebo for preventing or delaying the occurrence of pneumonia in ventilated patients colonized with…
- Trial name
- NCT00610623
- Testing
- azithromycin
- Where
- 20 sites in Belgium, France and 4 more
- Volunteers
- 92 people
- Sponsor
- Anbics Management-Services Ag
Primary Open Angle Glaucoma, Ocular Hypertension
A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
The purpose of this study is to evaluate efficacy and safety of CKD-351
- Trial name
- NCT04448223
- Testing
- CKD-351, Latanoprost+Dorzolmamide
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Respiratory Viral Infection
A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses
A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected…
- Trial name
- RESPIRE (NCT07633288)
- Testing
- AP1189, 100 mg
- Where
- 11 sites in Bosnia and Herzegovina, Montenegro and 2 more
- Volunteers
- 96 people
- Sponsor
- SynAct Pharma Aps
Postpartum Depression
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
- Trial name
- NCT02285504
- Testing
- SAGE-547
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Hemophilia
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtual-reality (VR) based…
- Trial name
- NCT05437211
- Testing
- Virtual-reality (VR) Based Solution
- Where
- 6 sites in France
- Volunteers
- 24 people
- Sponsor
- Takeda
Schnitzler Syndrome
Pilot Study of Dapansutrile Capsules in Schnitzler's Syndrome
This is a pilot, open-label Phase 2, single-center, repeat dose, single cohort, proof-of-concept, safety, pharmacodynamics and efficacy study of dapansutrile capsules to be conducted in subjects with Schnitzler's syndrome (SchS)…
- Trial name
- NCT03595371
- Testing
- dapansutrile
- Where
- Netherlands
- Volunteers
- 2 people
- Sponsor
- Olatec Therapeutics, Inc.
Participants With Underactive Bladder (UAB)
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
The objective of this POC (Phase 2a) study is to evaluate the effect on Bladder Voiding Efficiency (BVE) as well as safety of SFG-02 transdermal formulation in participants with UAB.
- Trial name
- NCT07906106
- Testing
- SFG-02
- Where
- 16 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Juro Sciences Inc.
Covid19
Remotely-conducted Trial of Famotidine vs Placebo for Patients at Home With Coronavirus (COVID) of 2019 (COVID-19)
Kit for reading vital signs (thermometer, wrist blood pressure device, finger oximeter) and with study drug is overnighted to qualified subjects with early symptoms of COVID-19.
- Trial name
- Pepcid4COV19 (NCT04565392)
- Testing
- Famotidine 20 milligram tablet
- Where
- United States
- Sponsor
- drpykessupplements.com
Non-Hodgkins Lymphoma, Multiple Myeloma
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
- Conditions
- Non-Hodgkins Lymphoma, Multiple Myeloma, B-All
- Trial name
- NCT02328014
- Testing
- Acalabrutinib, ACP-319
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acerta Pharma BV
Vital Signs
Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement
The impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a search for novel tools to stem the tide.
- Trial name
- MAC-VITAL (NCT04976907)
- Testing
- Contactless vital sign information collection
- Where
- 4 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Nuralogix Corporation
Body Odor
A Fifth Proof-of-Concept Study to Evaluate the Efficacy of NOBO, a Novel Postbiotic, in Controlling Axillary Odor in Healthy Adults
The goal of this clinical trial is to evaluate the performance of NOBO, a yeast-based fermentation product (postbiotic) designed to control axillary odor, in controlling axillary odor in healthy male and female adults age 18 - 70…
- Trial name
- NCT07884760
- Testing
- NOBO postbiotic
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kingdom