Clinical trials: Dose Finding Study
Hypertension
SPP100 Dose Finding Study in Japan
This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.
- Trial name
- NCT00311012
- Testing
- Aliskiren
- Where
- Japan
- Volunteers
- 445 people
- Sponsor
- Novartis
Gastrointestinal Cancer, Metastatic
A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers
This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with…
- Trial name
- NCT05087992
- Testing
- BI 905711, FOLFIRI, Bevacizumab
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 13 people
- Sponsor
- Boehringer Ingelheim
Neoplasms, Carcinoma, Non-Small-Cell Lung
This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.
This is a study in adults with advanced solid tumors including non-small cell lung cancer. The study tests the combination of two medicines called BI 754111 and BI 754091 that may help the immune system to fight the cancer.
- Trial name
- NCT03156114
- Testing
- Ezabenlimab, BI 754111
- Where
- 15 sites in United States, Canada and 3 more
- Volunteers
- 172 people
- Sponsor
- Boehringer Ingelheim
Anemia, Cancer
A Study of AMG 114 Administered by Subcutaneous Injection for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AMG 114 administered subcutaneously for the treatment of chemotherapy induced anemia in subjects receiving multicycle chemotherapy.
- Trial name
- NCT00119600
- Testing
- AMG 114
- Sponsor
- Amgen
Pain, Postoperative
Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed
The researchers in this study wanted to find out the optimal dose of Caffeine in the combination tablet of Naproxen Sodium and Caffeine that works in patients experiencing moderate to severe pain after having wisdom teeth…
- Trial name
- NCT04132336
- Testing
- Naproxen sodium/Caffeine (BAY2880376), Naproxen sodium (Aleve), Caffeine
- Where
- United States
- Volunteers
- 193 people
- Sponsor
- Bayer
Metastatic Breast Cancer
Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer
The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent…
- Trial name
- TRC105 (NCT01326481)
- Testing
- TRC105, Capecitabine
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Infectious Diarrhoea
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of…
- Trial name
- NCT03447821
- Testing
- 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage
- Volunteers
- 40 people
- Sponsor
- Cosmo Technologies Ltd
Endometriosis
Study to Evaluate the Pharmacodynamics and Efficacy of Leuprolide Tablets (Ovarest®) in Women With Endometriosis
The pharmacodynamic endpoint of percentage of subjects with suppressed estradiol level (less than 20 pg/mL) on cycle day 29 is the primary endpoint of the study.
- Trial name
- NCT05096065
- Testing
- Leuprolide Oral Tablet - 120 mg - QD- Treatment A, Leuprolide Oral Tablet - 80 mg - QD - Treatment B, Leuprolide Oral Tablet - 60 mg - QD - Treatment C
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Enteris BioPharma Inc.
Arthritis, Psoriatic
A Study to Test Different Doses of BI 730357 and Find Out Whether They Reduce Symptoms in People With Active Psoriatic Arthritis
This study is open to adults with active psoriatic arthritis who have tender and swollen joints. The purpose of this study is to find out whether a medicine called BI 730357 helps to reduce symptoms and to prevent damage to…
- Trial name
- NCT04680676
- Testing
- BI 730357
- Sponsor
- Boehringer Ingelheim
COVID-19 (Healthy Volunteers)
Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With Aluminum Hydroxide (COVID-19)
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine…
- Trial name
- NCT04742738
- Testing
- GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1, GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
- Where
- 12 sites in South Korea
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
Colitis Ulcerative
Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC.
- Trial name
- RESOLUTE (NCT05588843)
- Testing
- SAR443122
- Where
- 106 sites in United States, Argentina and 17 more
- Volunteers
- 187 people
- Sponsor
- Sanofi
Attention Deficit Hyperactivity Disorder, ADHD
Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
The purpose of the study is to evaluate the efficacy and safety of modafinil administered once daily for 9 weeks at doses of 255, 340, 425, and 510 mg as treatment for adults with ADHD.
- Trial name
- NCT00315276
- Testing
- Modafinil
- Where
- 18 sites in United States
- Volunteers
- 370 people
- Sponsor
- Cephalon
Refractory and/or Unexplained Chronic Cough
Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC).
- Trial name
- PAGANINI (NCT04562155)
- Testing
- BAY1817080
- Where
- 99 sites in United States, Argentina and 17 more
- Volunteers
- 310 people
- Sponsor
- Bayer
Muscle Loss, Obesity
Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists.
- Trial name
- QUALITY (NCT06282458)
- Testing
- Enobosarm, Semaglutide
- Where
- 14 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Veru Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT).
- Trial name
- NCT01835587
- Testing
- CC-486
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Celgene
Anemia, Chronic Kidney Disease
Peginesatide for Anemia in Chronic Hemodialysis Patients
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00228449
- Testing
- peginesatide
- Where
- 14 sites in United States
- Volunteers
- 165 people
- Sponsor
- Affymax
GSD1
Safety and Dose-Finding Study of DTX401 (AAV8G6PC) in Adults With Glycogen Storage Disease Type Ia (GSDIa)
The primary objective of the study is to determine the safety of single doses of DTX401, including the incidence of dose-limiting toxicities (DLTs) at each dose level.
- Trial name
- NCT03517085
- Testing
- DTX401, steroid regimen
- Where
- 6 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
COVID-19 (Healthy Volunteers)
Safety and Immunogenicity Study of SARS-CoV-2 Nanoparticle Vaccine (GBP510) Adjuvanted With or Without AS03 (COVID-19)
This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine…
- Trial name
- NCT04750343
- Testing
- GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1, GBP510 (RBD 10μg/dose) - Stage 1, Normal saline (0.9% sodium chloride solution) - Stage 1
- Where
- 14 sites in South Korea
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- SK Bioscience Co., Ltd.
Coronavirus
A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19
This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult…
- Trial name
- NCT04953078
- Testing
- Baiya SARS-CoV-2 Vax 1
- Where
- 2 sites in Thailand
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Baiya Phytopharm Co., Ltd.
Knee Osteoarthritis
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of…
- Trial name
- ALBATROSS-3 (NCT02205814)
- Testing
- Fasitibant- low dose, Fasitibant- intermediate dose, Fasitibant- high dose
- Where
- 25 sites in United States, Czechia and 2 more
- Volunteers
- 436 people
- Sponsor
- Menarini Group
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