Clinical trials: Dose Finding Study
Chronic Obstructive Pulmonary Disease (COPD)
Aclidinium/Formoterol Fixed Combination Dose Finding Study
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials
- Trial name
- NCT00626522
- Testing
- Aclidinium bromide and formoterol
- Where
- 9 sites in Australia, Czechia and 2 more
- Volunteers
- 808 people
- Sponsor
- AstraZeneca
Colon Cancer
An Open Dose-finding Study of Oral Applied Hexaminolevulinate (HAL) Imaging in Patients With Suspicion or High Risk of Neoplasia in the Colon
The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology.
- Trial name
- NCT01344902
- Testing
- hexaminolevulinate HCl
- Where
- Germany
- Volunteers
- 13 people
- Sponsor
- Photocure
Neuromuscular Blockade
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American…
- Trial name
- NCT03519854
- Testing
- Sugammadex, Esmeron®
- Volunteers
- 99 people
- Sponsor
- Merck Sharp & Dohme LLC
Brain Diseases, Spinal Cord Diseases
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine.
- Trial name
- NCT00862459
- Testing
- Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875), Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875)
- Where
- 27 sites in United States, Argentina and 2 more
- Volunteers
- 237 people
- Sponsor
- Bayer
Acute Myeloid Leukemia
Study to Find a Safe and Effective Dose of SKI-G-801 in the Treatment of Patients With Acute Myeloid Leukemia (AML)
This Phase I study is designed to assess the safety, tolerability, pharmacokinetics and anti-tumor effect of increasing doses of study drug SKI-G-801 in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are…
- Trial name
- NCT03564288
- Testing
- SKI-G-801
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Oscotec Inc.
Chronic Kidney Disease
A Study to Learn About How Well BAY3283142 Works and Its Safety in Participants With Chronic Kidney Disease
Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time.
- Trial name
- ALPINE 1 (NCT06522997)
- Testing
- BAY3283142
- Where
- 153 sites in United States, Argentina and 13 more
- Volunteers
- 1,222 people
- Sponsor
- Bayer
Malignant Solid Tumor - Malignant Nervous System Neoplasm
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
Primary Objectives: Phase 1 Part: To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid tumors including…
- Trial name
- NCT01751308
- Testing
- Cabazitaxel (XRP6258)
- Where
- 13 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Sanofi
Adeno-Associated Virus (AAV), Blood Coagulation Disorder
Dose-finding Study of SPK-8016 Gene Therapy in Patients With Hemophilia A to Support Evaluation in Individuals With FVIII Inhibitors
SPK-8016 is in development for the treatment of patients with inhibitors to FVIII. This Phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of SPK-8016 in adult males with…
- Conditions
- Adeno-Associated Virus (AAV), Blood Coagulation Disorder, Blood Coagulation Disorders, Inherited, Coagulation Protein Disorders
- Trial name
- NCT03734588
- Testing
- SPK-8016
- Where
- 11 sites in United States
- Volunteers
- 4 people
- Sponsor
- Spark Therapeutics, Inc.
Depressive Disorder, Major
A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
The purpose of this study is to assess the dose-response relationship of 2 doses of JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis results, compared to placebo as adjunctive therapy to an…
- Trial name
- NCT03227224
- Testing
- JNJ-42847922
- Where
- 101 sites in United States, Bulgaria and 6 more
- Volunteers
- 287 people
- Sponsor
- Janssen Research & Development, LLC
Atrial Fibrillation, Stroke
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient basis.
- Trial name
- NCT00806624
- Testing
- DU-176b tablets, Warfarin tablets
- Where
- 4 sites in China, Singapore and 2 more
- Volunteers
- 234 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Multiple Myeloma
A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant…
- Trial name
- 11-MM-01 (NCT01660750)
- Testing
- Carfilzomib, Cyclophosphamide, Dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 29 people
- Sponsor
- Criterium, Inc.
Chronic Pruritus
VPD-737 for Treatment of Chronic Pruritus
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments
- Trial name
- NCT01951274
- Testing
- VPD-737
- Where
- 25 sites in United States
- Volunteers
- 257 people
- Sponsor
- Vyne Therapeutics Inc.
Advanced Solid Tumor
A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors
Primary Objective: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment…
- Trial name
- NCT01755390
- Testing
- Cabazitaxel (XRP6258)
- Where
- 2 sites in France, Spain
- Volunteers
- 42 people
- Sponsor
- Sanofi
Hypertension
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
- Trial name
- NCT06857955
- Testing
- Saline, QCZ484
- Where
- 72 sites in United States, Japan and 1 more
- Volunteers
- 396 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Adult
PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors
The purpose of this first-in-human study of CX-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that…
- Trial name
- NCT03706274
- Testing
- CX-188
- Where
- United States
- Sponsor
- CytomX Therapeutics
Parkinson's Disease
A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy Men
A double-blind, randomised, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of V81444 in healthy male volunteers
- Trial name
- NCT01634568
- Testing
- V81444
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Vernalis (R&D) Ltd
Castration-resistant Prostate Cancer
Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
- Trial name
- NCT01634061
- Testing
- BEZ235, BKM120
- Where
- 10 sites in United States, Belgium and 4 more
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Cerebrovascular Accident
Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.
To evaluate the safety profiles of HTU-PA in patients with acute ischemic stroke.
- Trial name
- NCT00418275
- Testing
- Recombinant Human Plasminogen Activator (HTUPA)
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Global Biotech
Refractory Schizophrenia
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
- Trial name
- NCT03094429
- Testing
- NaBen®
- Where
- United States
- Volunteers
- 287 people
- Sponsor
- SyneuRx International (Taiwan) Corp
Hidradenitis Suppurativa
A Study to Investigate Efficacy and Safety With SAR445399 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
This is a multinational, randomized, double-blind, placebo-controlled, Phase 2, dose finding study to evaluate the efficacy and safety of different doses of SAR445399 in adult participants with moderate to severe hidradenitis…
- Trial name
- CLAROS (NCT07225569)
- Testing
- SAR445399
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 144 people
- Sponsor
- Sanofi
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