Clinical trials: Proof of Concept
Keratoconus
Study of TN-001 Topical Eyedrops for Keratoconus
The goal of this clinical trial is to learn if TN-001, a new eye-drop therapy, is safe and well-tolerated in adult patients with progressive keratoconus.
- Trial name
- NCT07388069
- Testing
- Low-dose TGF-B3 and Dexamethasone Sodium Phosphate, High-dose TGF-B3 and Dexamethasone Sodium Phosphate
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- TheiaNova Ltd.
HIV Infections
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
- Trial name
- CINNAMON (NCT06039579)
- Testing
- VH4004280, VH4011499, Antiretroviral therapy
- Where
- 20 sites in United States, Argentina and 7 more
- Volunteers
- 44 people
- Sponsor
- ViiV Healthcare
Post-traumatic Osteoarthritis of the Knee
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
- Trial name
- NCT02468583
- Testing
- FX006 32 mg, TCA IR 40 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Early Alzheimer's Disease
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
- Trial name
- NCT05161715
- Testing
- Obicetrapib
- Where
- Netherlands
- Volunteers
- 13 people
- Sponsor
- NewAmsterdam Pharma
Dentine Hypersensitivity
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity.
- Trial name
- NCT01691560
- Testing
- 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice, Sodium monofluorophosphate dentifrice
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- GlaxoSmithKline
Psoriasis Vulgaris
Evaluation of DD-25 Topical Cream for the Treatment of Psoriasis Vulgaris : Proof of Concept Study
The purpose of this study is to determine the efficacy of DD-25, a new topical drug, on plaque Psoriasis Vulgaris. The study will include subjects at plaque stage from 5-20% body area involvement.
- Trial name
- NCT01702324
- Testing
- DD-25
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Fortuderm Ltd.
AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Conditions
- AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MG, gMG
- Trial name
- NCT07284420
- Testing
- Efgartigimod IV, Empasiprubart IV
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 70 people
- Sponsor
- argenx
Endometriosis
Efficacy of SN132D in Patients With Suspected Endometriosis
This is a Phase IIa, open-label, non-randomised and non-placebo-controlled study. The study is designed to evaluate the diagnostic value and safety of a single intravenous dose of SN132D in up to 18 participants with suspected…
- Trial name
- NCT05664828
- Testing
- SN132D
- Where
- Sweden
- Volunteers
- 8 people
- Sponsor
- Spago Nanomedical AB
Hepatitis B
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with…
- Trial name
- POC_VAX-ID (NCT02186977)
- Testing
- VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD), 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novosanis NV
Alopecia Areata
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation.
- Trial name
- SIGNAL-AA (NCT06018428)
- Testing
- bempikibart (ADX-914)
- Where
- 33 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Q32 Bio Inc.
Diabetes Mellitus, Gestational Diabetes Mellitus (GDM)
A Proof of Concept (PoC), Randomized, Controlled Study to Validate the Algorithm and Evaluate the Accuracy, Safety and Pain Level of the Smartest-AE in Comparison to Self-measure Blood Glucose Levels
The study is conducted in Israel so plain language for the study is exist in Hebrew only
- Conditions
- Diabetes Mellitus, Gestational Diabetes Mellitus (GDM), Pre Diabetes
- Trial name
- NCT06587087
- Testing
- Smartest-AE: The lancet that will be used will be the Vitrex Soft Lite lll 28G.
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Smartest Technologies
Osteoarthritis
Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee
Primary Objective: To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee.
- Trial name
- NCT02845271
- Testing
- GZ389988, acetaminophen or paracetamol, fixed combination of paracetamol + codeine
- Where
- 2 sites in Germany
- Volunteers
- 104 people
- Sponsor
- Genzyme, a Sanofi Company
Healthy
Pharmacokinetic Comparison of XS003 and Tasigna
The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.
- Trial name
- NCT02068898
- Testing
- XS003, Tasigna
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- XSpray Microparticles
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics
Short Bowel Syndrome
Proof of Concept Study in Patients With Short Bowel Syndrome
This is a Phase I/II. proof of concept, open label, two-dose, dose escalation study of NM-002 in adult patients with SBS who previously responded to exenatide.
- Trial name
- NCT04379856
- Testing
- NM-002
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- 9 Meters Biopharma, Inc.
Advanced or Metastatic Hepatocellular Cancer, Advanced or Metastatic Ovarian Cancer
A Study With Tasquinimod Treating Patients With Hepatocellular, Ovarian, Renal Cell and Gastric Cancers
This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who…
- Conditions
- Advanced or Metastatic Hepatocellular Cancer, Advanced or Metastatic Ovarian Cancer, Metastatic Renal Cell Cancer, Advanced or Metastatic Gastric Carcinoma
- Trial name
- NCT01743469
- Testing
- Tasquinimod
- Where
- 24 sites in Belgium, Canada and 3 more
- Volunteers
- 201 people
- Sponsor
- Ipsen
Peanut Allergy
Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy
The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.
- Trial name
- NCT02920021
- Testing
- Etokimab
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- AnaptysBio, Inc.
Hematological Malignancies
Prevention of Acute Graft Versus Host Disease in Patients Undergoing Allogeneic ApoGraft Stem Cell Transplantation
Interventional, open label, Phase I/II, Safety and Proof-of-Concept Study, with a follow up period of 180 days after the transplantation of ApoGraft.
- Trial name
- NCT02828878
- Testing
- Allogeneic MPBC transplantation from matched related donor
- Where
- 2 sites in Israel
- Volunteers
- 12 people
- Sponsor
- Cellect Biotechnology
Chronic Obstructive Pulmonary Disease
IMD-1041 Chronic Obstructive Pulmonary Disease: Proof of Concept (POC) Study
COPD is a lung disease in which the lung is damaged, making it hard to breathe. In COPD, the airways/tubes that carry air in and out of the lungs are partly obstructed, making it difficult to get air in and out.
- Trial name
- COPD (NCT00883584)
- Testing
- IMD-1041
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Institute of Medicinal Molecular Design, Inc.