Clinical trials: Proof of Concept
HIV-1 Infection
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.
- Trial name
- NCT04041362
- Testing
- UB-421, Antiretroviral Therapy (ART)
- Sponsor
- United BioPharma
Alzheimer Disease
Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo
The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease
- Trial name
- NCT02240693
- Testing
- BI 409306
- Where
- 52 sites in United States, Austria and 10 more
- Volunteers
- 128 people
- Sponsor
- Boehringer Ingelheim
Dyslipidaemias, Dyslipidaemia
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving…
- Trial name
- NCT00158899
- Testing
- GW501516 oral tablets
- Where
- 64 sites in Belgium, Denmark and 9 more
- Volunteers
- 424 people
- Sponsor
- GlaxoSmithKline
Radiculopathy Lumbar
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule.
- Trial name
- NCT05298306
- Testing
- LAT8881
- Where
- Australia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Lateral Pharma Pty Ltd
Pneumocystis Pneumonia
Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults
This study aims to generate clinical data on the efficacy, safety, and tolerability of rezafungin combined with 7 days of co-trimoxazole for treatment of Pneumocystis pneumonia (PCP) in adults living with human immunodeficiency…
- Trial name
- NCT05835479
- Testing
- Co-Trimoxazole, Rezafungin Acetate / Co Trimoxazole
- Where
- 6 sites in South Africa
- Volunteers
- 50 people
- Sponsor
- Mundipharma Research Limited
Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients
A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients
Part I was a double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific…
- Trial name
- NCT00961896
- Testing
- Vehicle, LDE225 0.25%, LDE225 0.75%
- Where
- 3 sites in Austria, Switzerland
- Volunteers
- 18 people
- Sponsor
- Novartis Pharmaceuticals
Tension-Type Headache
Safety and Efficacy Study of TNX-201 Capsules for Treatment of Single Tension-Type Headache
This is a randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of a single dose of TNX-201 (140 mg) for the treatment of a single qualifying Tension-Type-Headache…
- Trial name
- NCT02423408
- Testing
- TNX-201
- Where
- 10 sites in United States
- Volunteers
- 165 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Ileus
Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing…
- Trial name
- NCT05056935
- Testing
- LB1148
- Where
- 6 sites in China
- Volunteers
- 131 people
- Sponsor
- Newsoara Biopharma Co., Ltd.
HIV-1 Infection
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo…
- Trial name
- NCT05056974
- Testing
- UB-421, chidamide
- Where
- Taiwan
- Volunteers
- 11 people
- Sponsor
- United BioPharma
Xeroderma Pigmentosum
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin.
- Trial name
- NCT05370235
- Testing
- Afamelanotide
- Where
- 2 sites in Belgium, Spain
- Volunteers
- 6 people
- Sponsor
- Clinuvel Europe Limited
Crohn's Disease
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
- Trial name
- NCT00584740
- Testing
- AIN457
- Where
- 2 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Critical Illness, Mechanical Ventilation
Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm
The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of…
- Trial name
- NCT02828722
- Testing
- Controlled light and noise, Controlled nutrition
- Where
- Hungary
- Volunteers
- 45 people
- Sponsor
- Achros Health Technologies Corporation
Cushings Disease, Cushing Disease
Safety and Efficacy of LCI699 in Cushing's Disease Patients
This exploratory study is a proof of concept study to determine whether LCI699 can safely reduce the level of urinary free cortisol in patients with Cushing's disease.
- Trial name
- NCT01331239
- Testing
- LCI699
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Peri-implant Mucositis
Efficacy of an Oral Hygiene Implant Protocol
This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared.
- Trial name
- NCT04462341
- Testing
- Water Flosser, Manual Toothbrush
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Water Pik, Inc.
Skin Aging
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product…
- Trial name
- NCT03180645
- Testing
- Test product (Moisturising cream), Positive control (Commercial market place moisturising cream), No treatment
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Essential Tremor, Movement Disorders
A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor
The purpose of this study is to evaluate the effectiveness, safety and tolerability of carisbamate treatment for the signs, symptoms, and impairment associated with Essential Tremor (ET) compared to placebo treatment.
- Trial name
- NCT00524056
- Testing
- Carisbamate
- Volunteers
- 62 people
- Sponsor
- SK Life Science, Inc.
Risk Behavior, Cognitive Decline
Intervention on Modifiable Lifestyle Risk Factors for Dementia Prevention
The overarching aim is to develop and deploy a multidomain intervention delivered on a mobile application to help older adults reduce their risk for dementia by improving a set of modifiable lifestyle risk factors associated with…
- Trial name
- NCT04616794
- Testing
- Cognitive Engagement Group, Physical Activity Group, Diet Group
- Where
- Canada
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- LuciLab
IBS - Irritable Bowel Syndrome
Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
- Trial name
- NCT04898257
- Testing
- Multistrain probiotic
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Larena SAS
Atopic Dermatitis
A First-in-Human PoC Study With BEN2293 in Patients With Mild to Moderate Atopic Dermatitis
A randomised, adaptive design, double-blind, placebo-controlled, first-in-human, two-part study to investigate the safety, tolerability, PK and preliminary efficacy of multiple topical doses of BEN2293 in patients with mild to…
- Trial name
- NCT04737304
- Where
- United Kingdom
- Volunteers
- 123 people
- Sponsor
- BenevolentAI Bio
Vasomotor Symptoms (VMS)
Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)
The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.
- Trial name
- NCT02049164
- Testing
- AR08
- Where
- 15 sites in United States
- Volunteers
- 32 people
- Sponsor
- Arbor Pharmaceuticals, Inc.