Clinical trials: Dose Finding Study
Neoplasms
Dose Finding Study of BI 836880 in Patients With Solid Tumors
This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours.
- Trial name
- NCT02674152
- Testing
- BI 836880
- Where
- 3 sites in France, Germany
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
- Trial name
- NCT00973349
- Testing
- MF59-eH1N1_f
- Where
- 21 sites in United States, Mexico
- Volunteers
- 2,719 people, healthy volunteers welcome
- Sponsor
- Novartis
Type 1 Diabetes Mellitus
Siplizumab in T1DM
This is a multicenter, Phase Ib, open-label, siplizumab dose-finding study in individuals aged 8-45 years with a Type 1 diabetes mellitus (T1DM) diagnosis. within 18 months of V0.
- Trial name
- DESIGNATE (NCT05574335)
- Testing
- Siplizumab
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Metastatic Solid Tumor
Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors
The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.
- Trial name
- NCT00611468
- Testing
- Topotecan, Erlotinib
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Accelerated Community Oncology Research Network
COVID-19
A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for…
- Trial name
- EMPATHY (NCT04828161)
- Testing
- ensovibep
- Where
- 48 sites in United States, Hungary and 3 more
- Volunteers
- 407 people
- Sponsor
- Novartis Pharmaceuticals
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection
This 48 week, phase 2b study in 150 HIV-1 infected antiretroviral therapy experienced adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of…
- Trial name
- SONNET (NCT01199731)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine
- Where
- 41 sites in United States, Belgium and 3 more
- Volunteers
- 30 people
- Sponsor
- ViiV Healthcare
Human Immunodeficiency Virus Type 1
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.
- Trial name
- NCT00110305
- Testing
- TMC278 25 mg, TMC278 75 mg, TMC278 150 mg
- Where
- 40 sites in United States, Argentina and 12 more
- Volunteers
- 368 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Phenylketonuria
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
The primary objective of the study is to evaluate the effect of dosing regimens of multiple subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while decreasing the frequency and severity of…
- Trial name
- NCT01560286
- Testing
- BMN 165 (rAvPAL-PEG)
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- BioMarin Pharmaceutical
Carcinoid Syndrome
Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome
The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.
- Trial name
- NCT01104415
- Testing
- Telotristat etiprate
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Lexicon Pharmaceuticals
Diabetic Macular Edema
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
- Trial name
- FAME (NCT00344968)
- Testing
- fluocinolone acetonide, Standard of care laser photocoagulation
- Where
- United States
- Volunteers
- 956 people
- Sponsor
- Alimera Sciences
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Ischemic Stroke
Dose Finding Study of MCI-186 in Acute Ischemic Stroke
To investigate the efficacy and safety of MCI-186 (bolus followed by continuous infusion) in acute ischemic stroke patients through a double-blind, parallel-group comparison with the existing MCI-186 dosing regimen…
- Trial name
- NCT03346538
- Testing
- Continuous infusion high-dose MCI-186, Continuous infusion low-dose MCI-186, Approved dosing regimen MCI-186
- Where
- 45 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Shionogi
Hemophilia B
Safety and Dose Finding Study of DTX101 (AAVrh10FIX) in Adults With Moderate/Severe to Severe Hemophilia B
A Phase 1/2, open-label, dose-finding safety study of single ascending doses of DTX101 in adult males with moderate/severe to severe hemophilia B.
- Trial name
- NCT02618915
- Testing
- DTX101
- Where
- 9 sites in United States, Bulgaria and 1 more
- Volunteers
- 6 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Central Neuropathic Pain, Multiple Sclerosis
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.
- Trial name
- PRIME (NCT01324232)
- Testing
- AVP-923-45, AVP-923-30, AVP-923-20
- Where
- 72 sites in United States, Argentina and 3 more
- Volunteers
- 209 people
- Sponsor
- Avanir Pharmaceuticals
Erythematotelangiectatic Rosacea
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single…
- Trial name
- NCT00989014
- Testing
- CD07805/47
- Where
- 5 sites in United States
- Volunteers
- 122 people
- Sponsor
- Galderma R&D
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
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
Pain, Postoperative
Intrathecal Paracetamol Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Short Knee Procedures
This is a phase II, single centre, randomised, parallel-group, double-blind, three doses, placebo-controlled, exploratory efficacy and safety study.
- Trial name
- NCT03428230
- Testing
- 30 mg Paracetamol 3% (1 mL), 60 mg Paracetamol 3% (2 mL), 90 mg Paracetamol 3% (3 mL)
- Where
- Switzerland
- Volunteers
- 60 people
- Sponsor
- Sintetica SA
Follicular Lymphoma
A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma
This study focuses on finding a safe and tolerable dose for a three-drug regimen that combines venetoclax (Venclexta Ⓡ), CC-486 (also known as oral azacitidine) and obinutuzumab (Gazyva Ⓡ) to treat cancer participants who have…
- Trial name
- NCT04722601
- Testing
- Venetoclax, Obinutuzumab, CC-486
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Chicago