Clinical trials: Proof of Concept
Neuropathy;Peripheral, Chemotherapy-induced Peripheral Neuropathy
BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients
This study will assess pharmacokinetic (PK)/pharmacodynamic (PD) relationships and whether BXQ-350 may decrease the intensity and/or duration of chemotherapy induced peripheral neuropathy (CIPN) thereby improving quality of life…
- Trial name
- RETRO (NCT05291286)
- Testing
- BXQ-350
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Bexion Pharmaceuticals, Inc.
Uveitis Posterior Non-Infectious, Uveitis, Intermediate
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU
This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.
- Conditions
- Uveitis Posterior Non-Infectious, Uveitis, Intermediate, Noninfectious Panuveitis
- Trial name
- OPTYK-1 (NCT05953688)
- Testing
- ESK-001
- Where
- 17 sites in United States
- Volunteers
- 36 people
- Sponsor
- Alumis Inc
Autism Spectrum Disorder
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD.
- Trial name
- NCT01793441
- Testing
- RG7314
- Where
- 56 sites in United States
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
Pembrolizumab Alone and In Combination With Acalabrutinib (ACP-196) in Subjects With Advanced Non-small Cell Lung Cancer
Pembrolizumab alone and in combination with acalabrutinib in subjects with advanced non-small cell lung cancer.
- Trial name
- KEYNOTE166 (NCT02448303)
- Testing
- Pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Acerta Pharma BV
Multiple Sclerosis
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI…
- Trial name
- NCT04879628
- Testing
- SAR441344 IV, SAR441344 SC, MRI contrast-enhancing preparations
- Where
- 37 sites in United States, Bulgaria and 8 more
- Volunteers
- 129 people
- Sponsor
- Sanofi
Osteoporosis
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
This study will evaluate the effect of a 1-year administration of the vitamin D analog 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3 (DP001) on bone mineral density (BMD), safety, and tolerability.
- Trial name
- 2MD-3H-2B (NCT00715676)
- Testing
- DP001
- Where
- 9 sites in United States
- Volunteers
- 157 people
- Sponsor
- Deltanoid Pharmaceuticals
Advanced Pancreatic Cancer
A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected…
- Trial name
- NCT01303172
- Testing
- IMM-101, Gemcitabine
- Where
- 21 sites in Cyprus, Ireland and 3 more
- Volunteers
- 110 people
- Sponsor
- Immodulon Therapeutics Ltd
Hypertension, Diabetes
Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus…
- Trial name
- NCT01496430
- Testing
- Azilsartan medoxomil
- Where
- 68 sites in United States
- Volunteers
- 105 people
- Sponsor
- Takeda
Covid-19
Double-blind Study to Evaluate the Safety and Efficacy of Antroquinonol in Mild-Moderate COVID-19 Hospitalized Patients
To evaluate the safety and efficacy of antroquinonol treatment of mild to moderate pneumonia due to COVID-19, as measured by the proportion of patients alive and free of respiratory failure.
- Trial name
- NCT04523181
- Testing
- Antroquinonol
- Where
- 15 sites in United States, Argentina and 1 more
- Volunteers
- 124 people
- Sponsor
- Golden Biotechnology Corporation
Histopathology
Histological Analysis of Bellafill Injected Tissue at Various Time Points
This is a prospective, in vivo proof-of-concept clinical study, where histopathologic examinations will be conducted at various timepoints following Bellafill injections.
- Trial name
- NCT03327311
- Testing
- Bellafill
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Suneva Medical, Inc.
Age-Related Macular Degeneration
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
- Trial name
- RADIANT (NCT02467634)
- Testing
- HuCNS-SC sub-retinal transplantation
- Where
- 12 sites in United States
- Volunteers
- 3 people
- Sponsor
- StemCells, Inc.
Colitis, Ulcerative
Budesonide 9 mg Capsules in Active UC
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
- Trial name
- TOPICAL-1 (NCT02550418)
- Testing
- Budesonide
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Dr. Falk Pharma GmbH
Cancer Survivors, Healthy Participant
A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors
This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system)…
- Conditions
- Cancer Survivors, Healthy Participant, Elderly
- Trial name
- GIANTS-1 (NCT07363057)
- Testing
- GI-102 in combination with GIB-7
- Where
- 2 sites in Australia
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GI Innovation, Inc.
Keratitis
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered…
- Trial name
- FAST (NCT03237936)
- Testing
- 1mg/mL ciclosporin
- Where
- France
- Volunteers
- 17 people
- Sponsor
- Santen SAS
Obesity
A 35 Day Study to Investigate the Effects of GSK1521498 on Bodyweight in Obese Subjects With Over-Eating Behaviours.
The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours.
- Trial name
- NCT01195792
- Testing
- GSK1521498
- Where
- 3 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Scleroderma, Systemic, Sclerosis, Systemic
Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease
The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.
- Conditions
- Scleroderma, Systemic, Sclerosis, Systemic, Systemic Scleroderma, Systemic Sclerosis
- Trial name
- NCT01559129
- Testing
- Pomalidomide (CC-4047)
- Where
- 56 sites in United States, Australia and 8 more
- Volunteers
- 23 people
- Sponsor
- Celgene
Nasolabial Fold Wrinkles
CelluJuve® for the Treatment of Moderate to Severe NLFs
Single-center, open-label proof of concept study assessing the safety and effectiveness of CelluJuve® for the treatment of moderate to severe NLFs
- Trial name
- NCT07545980
- Testing
- CelluJuve®
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Spiderwort Biotechnologies Inc.
Cutaneous Squamous Cell Carcinoma in Situ (CSCCis)
Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
The purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ (SCCis) to enable further clinical…
- Trial name
- NCT03333694
- Testing
- Cutaneous Cream application
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Retinal Detachment
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes
Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.
- Trial name
- NCT02715388
- Testing
- GlasScope Surgical Microscope
- Where
- Israel
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Elbit Systems LTD
Exocrine Pancreatic Insufficiency
Oral CDX-7108 in Healthy Adults and EPI Subjects
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency.
- Trial name
- NCT05082051
- Testing
- Part A, Part B, Part C
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)