Clinical trials: Dose Escalation and Safety
Loiasis
Efficacy and Microfilaricidal Kinetics of Imatinib for the Treatment of Loa Loa
Background: Many people who live in west or central Africa are at risk for infection from a very small worm called Loa loa. This infection is acquired through the bite of a fly. Baby worms called microfilariae live in the blood.
- Trial name
- NCT02644525
- Testing
- Imatinib Mesylate
- Where
- Cameroon
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Single Rising Dose Trial of BI 425809 for Healthy Japanese and Chinese Male Subjects
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics…
- Trial name
- NCT02383888
- Testing
- BI 425809
- Where
- South Korea
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Malaria
Trial to Evaluate CIS43LS in Healthy Adults
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection.
- Trial name
- NCT04206332
- Testing
- VRC-MALMAB0100-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- 2 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Bipolar Depression
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
- Trial name
- NCT00926393
- Testing
- Quetiapine Immediate Release, Quetiapine Extended Release
- Volunteers
- 139 people
- Sponsor
- AstraZeneca
Osteochondrodysplasia
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia
This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.
- Trial name
- upreACH-2 (NCT06067425)
- Testing
- SAR442501
- Where
- 9 sites in Australia, China and 3 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
Cancer
Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.
- Trial name
- NCT00415636
- Testing
- IC83/LY2603618, pemetrexed
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Eli Lilly and Company
Gastroenteritis Escherichia Coli, Immunisation
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135…
- Trial name
- NCT03548064
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Urinary Bladder Cancer, Melanoma
MAGE-A4ᶜ¹º³²T for Multi-Tumor
This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung…
- Conditions
- Urinary Bladder Cancer, Melanoma, Head and Neck Cancer, Ovarian Cancer
- Trial name
- NCT03132922
- Testing
- Autologous genetically modified MAGE-A4ᶜ¹º³²T cells, Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
- Where
- 11 sites in United States, Canada
- Volunteers
- 71 people
- Sponsor
- USWM CT, LLC
Fallopian Tube Cancer, Ovarian Cancer
Autologous T Cells With or Without Cyclophosphamide and Fludarabine in Treating Patients With Recurrent or Persistent Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer (Fludarabine Treatment Closed as of 12/01/2009)
RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Trial name
- NCT00562640
- Testing
- filgrastim, therapeutic autologous lymphocytes, cyclophosphamide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer
Study of ADCT-301 in Patients With Selected Advanced Solid Tumors
This study evaluates ADCT-301 in patients with Selected Advanced Solid Tumors. Patients will participate in a Treatment Period with 3-week cycles and a Follow-up Period every 12 weeks for up to 1 year after treatment…
- Conditions
- Head and Neck Cancer Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Gastric Cancer, Esophageal Cancer
- Trial name
- NCT03621982
- Testing
- ADCT-301, Pembrolizumab
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 78 people
- Sponsor
- ADC Therapeutics S.A.
Schistosomiasis
Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults
This is a Phase 1, open-label, dose-escalation clinical trial to evaluate the safety, reactogenicity, and immunogenicity of the Sm-p80+GLA-SE vaccine candidate in healthy adults between 18 and 55 years of age.
- Trial name
- NCT05292391
- Testing
- Sm-p80, Sm-p80 + GLA-SE
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Solid Tumor
BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
This was an open-label, multicenter Phase I/IIa dose escalation, safety, pharmacokinetic and pharmacodynamic (PD) study of BNT151 with expansion cohorts in various solid tumor indications.
- Trial name
- NCT04455620
- Testing
- BNT151
- Where
- 6 sites in United States, Spain
- Volunteers
- 49 people
- Sponsor
- BioNTech SE
Hypertension
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure…
- Trial name
- NCT00439738
- Testing
- HCTZ + Amlodipine, Valsartan/HCTZ
- Where
- 5 sites in United States
- Volunteers
- 412 people
- Sponsor
- Novartis Pharmaceuticals
Liver Disease
A Phase I/II Safety and Tolerability Dose Escalation Study of Autologous Stem Cells to Patients With Liver Insufficiency
This is a prospective dose escalation study of the administration of adult human stem cells in patients with end stage liver failure.
- Trial name
- NCT00655707
- Testing
- Autologous Expanded CD34+ Haemopoietic cells
- Where
- United Kingdom
- Volunteers
- 5 people
- Sponsor
- Imperial College London
Neovascular Age-related Macular Degeneration
Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD
To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)
- Trial name
- OASIS (NCT04626128)
- Testing
- CLS-AX, Anti-VEGF
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Clearside Biomedical, Inc.
Metastatic Colorectal Cancer
Sym004 in Patients With Advanced Solid Tumors
This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.
- Trial name
- NCT01117428
- Testing
- Sym004
- Where
- 7 sites in United States, Belgium and 1 more
- Volunteers
- 111 people
- Sponsor
- Symphogen A/S
Liver Cirrhosis
A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients
To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.
- Trial name
- NCT00592475
- Testing
- conivaptan
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Cumberland Pharmaceuticals
Asthma
Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma.
- Trial name
- NCT00679263
- Testing
- MN-221
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- MediciNova
Healthy
A Study of LY2541546 in Healthy Postmenopausal Women
The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.
- Trial name
- NCT01742078
- Testing
- LY2541546 - IV, LY2541546 - SC
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Myelodysplastic Syndromes, Myeloproliferative Disorders
Busulfan Safety/Efficacy as Conditioning Prior to Hematopoietic Cell Transplantation (HCT)
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6, -5, -4, and -3. Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve (AUC).
- Conditions
- Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Lymphocytic, Myeloma
- Trial name
- NCT00361140
- Testing
- Busulfan, Fludarabine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute