Clinical trials: Dose-Finding Study
Neoplasms
A Study of BI 853520 in Japanese and Taiwanese Patients With Various Types of Advanced or Metastatic Cancer
The primary objective of this trial is to explore the safety and tolerability of BI 853520 monotherapy and determine the maximum tolerated dose (MTD) for Japanese and Taiwanese patients with advanced or metastatic solid tumours.
- Trial name
- NCT01905111
- Testing
- BI 853520
- Where
- 2 sites in Japan, Taiwan
- Volunteers
- 21 people
- Sponsor
- Boehringer Ingelheim
Mild to Moderate Ulcerative Colitis
A Study of SPH3127 in the Treatment of Mild to Moderate Ulcerative Colitis
To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.
- Trial name
- NCT05770609
- Testing
- SPH3127 Tablets with Dose A, SPH3127 Tablets with Dose B
- Where
- 25 sites in China
- Volunteers
- 53 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Peripheral Arterial Occlusive Disease
Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication
The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo. The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.
- Trial name
- TALISMAN 211 (NCT01157871)
- Testing
- XRP0038 (NV1FGF)
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 36 people
- Sponsor
- Sanofi
Gastrointestinal Dysmotility
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.
- Trial name
- NCT01280344
- Testing
- Saline Solution for Injection, Ipamorelin
- Where
- 45 sites in United States
- Volunteers
- 320 people
- Sponsor
- Helsinn Therapeutics (U.S.), Inc
Advanced Solid Tumor
FGFR Inhibitor ET0111 Monotherapy in Patients With Advanced Solid Tumors
This is a Phase I, open-label, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0111 in patients with advanced solid tumors.
- Trial name
- FLIGHT (NCT05522309)
- Testing
- ET0111
- Where
- 5 sites in China
- Volunteers
- 37 people
- Sponsor
- Etern BioPharma (Shanghai) Co., Ltd
Chronic Graft Versus Host Disease
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
- Trial name
- NCT03790332
- Testing
- Ibrutinib
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 59 people
- Sponsor
- Pharmacyclics LLC.
Extensive Stage Small Cell Lung Cancer
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment…
- Trial name
- NCT05142696
- Testing
- [177Lu]Lu-DOTA-TATE, Atezolizumab, [68Ga]Ga-DOTA-TATE
- Where
- 27 sites in United States, Austria and 10 more
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Hypoactive Sexual Desire Disorder
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive…
- Trial name
- NCT02101203
- Testing
- 0.5 mgTestosterone + 10 mg Buspirone
- Where
- 10 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Emotional Brain NY Inc.
Gastroesophageal Reflux Disease
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent…
- Trial name
- NCT01472939
- Testing
- SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI, SSP-002358 (2.0 mg) + PPI
- Where
- 88 sites in United States, Czechia and 4 more
- Volunteers
- 480 people
- Sponsor
- Shire
Phenylketonuria
Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)
This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain reduced blood Phe concentrations in PKU subjects.
- Trial name
- NCT00924703
- Testing
- rAvPAL-PEG
- Where
- 14 sites in United States
- Volunteers
- 68 people
- Sponsor
- BioMarin Pharmaceutical
Pain
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose.
- Trial name
- OA19 (NCT00878501)
- Testing
- AZD1386
- Where
- 41 sites in Bulgaria, Canada and 5 more
- Volunteers
- 241 people
- Sponsor
- AstraZeneca
Peripheral Arterial Disease, Diabetic Foot
Efficacy and Safety of Intramuscular PDA-002 in Subjects With Diabetic Foot Ulcer With and Without PAD.
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study evaluating the efficacy and safety of intramuscular administration of human placenta-derived cells (PDA-002) in subjects with…
- Trial name
- DFU-002 (NCT02264288)
- Testing
- PDA-002
- Where
- 45 sites in United States
- Volunteers
- 159 people
- Sponsor
- Celularity Incorporated
Severe Malaria
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum Malaria
The purpose of this study was to identify the safe and effective dose of intravenous cipargamin in participants with moderately severe and severe malaria.
- Trial name
- NCT04675931
- Testing
- Cipargamin, IV Artesunate, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 5 more
- Volunteers
- 254 people
- Sponsor
- Novartis Pharmaceuticals
Parkinson Disease (PD), Idiopathic Parkinson's Disease
Assessment of the Safety, Immunogenicity, and Pharmacodynamics of TRB-001 in Patients With Early Idiopathic Parkinson's Disease
This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients.
- Trial name
- NCT07840027
- Testing
- TRB-001
- Where
- Austria
- Volunteers
- 36 people
- Sponsor
- Tridem Bioscience FlexCo
Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection
Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients
Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is…
- Trial name
- NCT01198522
- Testing
- L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine
- Where
- 5 sites in Germany, Italy
- Volunteers
- 28 people
- Sponsor
- Philogen S.p.A.
Asthma
A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose…
- Trial name
- Levante (NCT06529419)
- Testing
- AZD8630, Inhaler
- Where
- 196 sites in United States, Argentina and 21 more
- Volunteers
- 537 people
- Sponsor
- AstraZeneca
B-cell Lymphoma
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.
- Trial name
- NCT03424122
- Testing
- Parsaclisib, Rituximab, Bendamustine
- Where
- 21 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Incyte Corporation
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma, Immunotherapy, Allergen
Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose. 4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therapy 20 weeks.
- Trial name
- NCT01144429
- Testing
- Allergoid, allergenic extract of 100% Birch
- Where
- 39 sites in Germany, Lithuania and 1 more
- Volunteers
- 344 people
- Sponsor
- Leti Pharma GmbH
Sickle Cell Disease, Sickle Cell Anemia
A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.
ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel in human red blood cells (RBCs) that blocks…
- Trial name
- NCT00040677
- Testing
- Low Dose ICA-17043, High dose ICA-17043
- Where
- 19 sites in United States
- Volunteers
- 90 people
- Sponsor
- Icagen