Clinical trials: Dose Finding Study
Osteoarthritis, Osteoarthritis, Knee
A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
- Trial name
- NCT05337540
- Testing
- EVI-01, Active comparator Synvisc-One
- Where
- 2 sites in Brazil
- Volunteers
- 120 people
- Sponsor
- Aptissen SA
Autosomal Dominant Polycystic Kidney Disease
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1.
- Trial name
- NCT01210560
- Testing
- Tolvaptan MR, Tolvaptan IR
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pain
A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery
Primary Objective： To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery.
- Trial name
- NCT06680466
- Testing
- YZJ-4729, morphine
- Where
- China
- Volunteers
- 179 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Crohn's Disease
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment…
- Trial name
- NCT00989573
- Testing
- OPC-6535
- Where
- 11 sites in Japan, South Korea
- Volunteers
- 191 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Primary Open Angle Glaucoma, Ocular Hypertension
Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
This study will evaluate the safety and efficacy of PF 03187207.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension, Pigmentary Glaucoma, Pseudoexfoliative Glaucoma
- Trial name
- NCT00441883
- Testing
- PF-03187207 and Latanoprost Vehicle, Latanoprost 0.005% and PF-03187207 Vehicle
- Where
- 19 sites in United States
- Volunteers
- 176 people
- Sponsor
- Bausch & Lomb Incorporated
Parkinson's Disease
Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's Disease
The main purpose of this study is to determine the safety of BIIB014 and how well BIIB014 is tolerated when given at different doses to patients with early-stage Parkinson's Disease.
- Trial name
- MOBILE (NCT00442780)
- Testing
- BIIB014
- Where
- 10 sites in Israel, Poland and 1 more
- Volunteers
- 36 people
- Sponsor
- Biogen
Asthma
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation solution will be investigated in subjects with mild bronchial asthma.
- Trial name
- NCT01478152
- Testing
- Drug-like Medical Device: Ectoin Inhalation Solution
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Bitop AG
Atrial Fibrillation
Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
- Trial name
- NCT03398434
- Testing
- MAA868, Apixaban
- Sponsor
- Novartis Pharmaceuticals
Gastrointestinal Endoscopy, Gastrointestinal Polypectomy
Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
- Trial name
- NCT01189604
- Testing
- ICI35,868 (propofol)
- Where
- 2 sites in Japan
- Volunteers
- 123 people
- Sponsor
- AstraZeneca
Mast Cell Activation Syndrome
Masitinib for the Treatment of Severe Mast Cell Activation Syndrome
To evaluate the efficacy and safety of two dosing schemes of oral masitinib versus matching placebo in the treatment of patients suffering from severe MCAS with handicap unresponsive to optimal symptomatic treatment.
- Trial name
- NCT05449444
- Testing
- Masitinib 4.5 mg/kg/day, Best supportive care, Masitinib 6.0 mg/kg/day
- Where
- 4 sites in United States, France
- Volunteers
- 72 people
- Sponsor
- AB Science
GBM, Glioblastoma
PVSRIPO for Recurrent Glioblastoma (GBM)
Purpose of the Study: To determine the maximally tolerated dose (MTD) and the Recommended Phase 2 Dose (RP2D) of PVSRIPO when delivered intracerebrally by convection-enhanced delivery (CED).
- Conditions
- GBM, Glioblastoma, Glioma, Malignant Glioma
- Trial name
- PVSRIPO (NCT01491893)
- Testing
- Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Istari Oncology, Inc.
Metastatic Breast Cancer
A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer
- Trial name
- DB-08 (NCT04556773)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 138 people
- Sponsor
- AstraZeneca
GERD
A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
The purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (XP19986) compared to placebo in patients with gastroesophageal reflux disease.
- Trial name
- NCT00838396
- Testing
- XP19986 CR
- Where
- 3 sites in United States
- Volunteers
- 58 people
- Sponsor
- Indivior Inc.
Peripheral Arterial Disease
Evaluation of Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients With Peripheral Arterial Disease
The goal of this clinical trial is to study the safety and tolerability of Etrinabdione in adult patients with peripheral arterial disease. It will also learn about the preliminary efficacy of Etrinabdione.
- Trial name
- CLAUDIA (NCT06774040)
- Testing
- Etribnabdione 25 mg BID, Etribnabdione 50 mg BID
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- VivaCell Biotechnology España
Advanced Solid Tumors
A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors
Researchers are looking for a better way to treat people who have advanced solid tumors. Advanced solid tumors are solid cancers that may have spread to nearby tissue, lymph nodes and/or to distant parts of the body and that are…
- Trial name
- NCT05537740
- Testing
- BAY3375968, Pembrolizumab
- Where
- 26 sites in United States, Belgium and 6 more
- Volunteers
- 129 people
- Sponsor
- Bayer
Hypertension
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension
- Trial name
- NCT07352969
- Testing
- IBI3016
- Where
- China
- Volunteers
- 352 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Pulmonary Arterial Hypertension
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial…
- Trial name
- AIR001-CS02 (NCT00814645)
- Testing
- Sodium Nitrite Inhalation Solution
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Aires Pharmaceuticals, Inc.
Advanced Solid Tumor
Study of DNP002 in Patients With Solid Tumors
This is an open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6…
- Trial name
- NCT06466265
- Testing
- DNP002
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Kumho HT Inc.
Dose Finding Study
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-438 in Healthy Male Participants
The purpose of this study was to evaluate the safety and pharmacokinetics of TAK-438 following multiple oral doses to healthy adult Japanese male participants
- Trial name
- NCT02123953
- Testing
- TAK-438
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Takeda
Japanese Encephalitis Virus Disease
A Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis Messenger Ribonucleic Acid (mRNA) Vaccines (GBP560) in Healthy Adults
This is a 2-Stage, Phase I/II Study to Assess the Safety, Reactogenicity, and Immunogenicity of SK Japanese Encephalitis mRNA Vaccines (GBP560) in Healthy Adults (Aged 18 Years and Older)
- Trial name
- NCT06680128
- Testing
- GBP560-A, GBP560-B, IXIARO
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
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