Clinical trials: Proof of Concept
Diabetic Macular Edema
Multiple Dose Safety and Efficacy of LKA651 in Patients With Diabetic Macular Edema
The primary objectives of this study were to evaluate the safety and efficacy of LKA651 in patients with macular edema from diabetic macular edema (DME),
- Trial name
- NCT03927690
- Testing
- LKA651, Lucentis
- Where
- 22 sites in United States, Germany and 3 more
- Volunteers
- 91 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Foot Ulcer
Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study
The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.
- Trial name
- BBR-012 (NCT01342497)
- Testing
- isoniazide
- Where
- 11 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Bridge BioResearch Ltd.
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
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
Septic Shock
Treatment of Patients With Early Septic Shock and Bio-Adrenomedullin(ADM) Concentration > 70 pg/ml With ADRECIZUMAB
This is a double-blind, placebo-controlled, randomized, multicenter proof of concept and dose-finding phase II study using two doses of ADRECIZUMAB in patients with early septic shock and a bio-ADM plasma concentration at…
- Trial name
- AdrenOSS-2 (NCT03085758)
- Testing
- Adrecizumab
- Where
- 30 sites in Belgium, France and 2 more
- Volunteers
- 301 people
- Sponsor
- Adrenomed AG
Wet Age-related Macular Degeneration
AAVCAGsCD59 for the Treatment of Wet AMD
Patients with treatment naive wet AMD will receive an intravitreal anti-VEGF injection at Day 0 followed by an intravitreal injection of AAVCAGsCD59 at Day 7.
- Trial name
- NCT03585556
- Testing
- Intravitreal anti-VEGF, Intravitreal AAVCAGsCD59, Oral prednisolone
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Janssen Research & Development, LLC
Discoid Lupus Erythematosus
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.
- Trial name
- NCT00625157
- Testing
- ASF 1096 0.5 % cream
- Where
- Denmark
- Sponsor
- Astion Pharma A/S
Breast Cancer, Hypercalcemia of Malignancy
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering…
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer
- Trial name
- NCT00896454
- Testing
- denosumab
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 33 people
- Sponsor
- Amgen
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Metastatic Colorectal Cancer
Sotevtamab (AB-16B5) Combined With FOLFOX as Neoadjuvant Treatment Prior to Resection of Colorectal Cancer Liver Metastasis
This Phase II study will recruit 17 colorectal cancer patients with liver-dominant metastases. All recruited patients will receive Sotevtamab at a dose of 800 mg once weekly for 6 cycles combined with FOLFOX once every 2 weeks…
- Trial name
- EGIA-003 (NCT06225843)
- Testing
- Sotevtamab, FOLFOX
- Where
- Canada
- Volunteers
- 17 people
- Sponsor
- Alethia Biotherapeutics
Primary Sclerosing Cholangitis
PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC).
- Trial name
- NCT02653625
- Testing
- Cenicriviroc 150 mg
- Where
- 9 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- Tobira Therapeutics, Inc.
Relapsed or Plateau-Phase Multiple Myeloma
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
- Trial name
- NCT00259740
- Testing
- DENOSUMAB
- Volunteers
- 96 people
- Sponsor
- Amgen
Alzheimer Disease
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in…
- Trial name
- Sirocco (NCT00501111)
- Testing
- AZD3480, Donepezil
- Where
- 70 sites in Austria, Belgium and 8 more
- Volunteers
- 659 people
- Sponsor
- AstraZeneca
Overweight and Obesity, Healthy
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist
Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily [BID]) or placebo for 5 days beginning on Day 1.
- Trial name
- NCT06500429
- Testing
- NG101, Semaglutide Injectable Product
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Neurogastrx, Inc.
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
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
Primary Sclerosing Cholangitis (PSC)
A POC and Dose-Ranging Study of HTD1801 in PSC Patients
The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.
- Trial name
- NCT03333928
- Testing
- HTD1801
- Where
- 26 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Plaque Type Psoriasis
SHP-141C in Plaque Type Psoriasis
The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.
- Trial name
- NCT01646567
- Testing
- SHP-141C, Betamethasone Valerate, Calcipotriol
- Where
- Australia
- Volunteers
- 14 people
- Sponsor
- TetraLogic Pharmaceuticals
COVID-19
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
- Trial name
- NCT04676971
- Testing
- hzVSF-v13
- Where
- 9 sites in Italy, Russia
- Volunteers
- 115 people
- Sponsor
- ImmuneMed, Inc.
Chronic Kidney Disease
A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease
The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in participants with chronic kidney disease with or without type 2 diabetes…
- Trial name
- NCT06717698
- Testing
- NNC0519-0130, Semaglutide
- Where
- 147 sites in United States, Argentina and 12 more
- Volunteers
- 465 people
- Sponsor
- Novo Nordisk A/S