Clinical trials: Dose Finding Study
Phenylketonuria
Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU
The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.
- Trial name
- NCT00925054
- Testing
- rAvPAL-PEG 0.001 mg/kg, rAvPAL-PEG 0.003 mg/kg, rAvPAL-PEG 0.01 mg/kg
- Where
- 11 sites in United States
- Volunteers
- 40 people
- Sponsor
- BioMarin Pharmaceutical
Heart Failure
BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease
A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
- Trial name
- ARTS (NCT01345656)
- Testing
- BAY94-8862, Spironolactone
- Where
- 50 sites in Austria, Belgium and 8 more
- Volunteers
- 457 people
- Sponsor
- Bayer
Metastatic Castration-resistant Prostate Cancer
[Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
Phase 1: The objective of the Phase 1 part of the clinical trial is to verify safety and tolerability (dose-limiting toxicity [DLT], maximum tolerated dose [MTD]) of a single 3.7 Giga-Becquerel (GBq) dose with the potential for…
- Trial name
- LUCIDA (NCT05458544)
- Testing
- [177Lu]Ludotadipep 3.7 GBq
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- FutureChem
Multiple Myeloma
A Safety and Efficacy Study of Carfilzomib and Pomalidomide With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory multiple…
- Trial name
- NCT01464034
- Testing
- Carfilzomib, Pomalidomide, Dexamethasone
- Where
- 9 sites in United States
- Volunteers
- 136 people
- Sponsor
- Criterium, Inc.
Rheumatoid Arthritis (RA)
A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis
The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid…
- Trial name
- DekaJoint (NCT07245992)
- Testing
- F8IL10
- Where
- 2 sites in Italy
- Volunteers
- 54 people
- Sponsor
- Philogen S.p.A.
Locally Advanced or Metastatic Solid Tumors
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
- Trial name
- NCT05205109
- Testing
- ATG-037, KEYTRUDA ®( Pembrolizumab)
- Where
- 7 sites in Australia, China
- Volunteers
- 98 people
- Sponsor
- Antengene Therapeutics Limited
Liver Carcinoma
Dose Finding Study of AVE1642 in Patients With Advanced or Metastatic Liver Carcinoma
The primary objective of the study is to select the dose of AVE1642 to be administered in patients with liver carcinoma not eligible for local treatment.
- Trial name
- NCT00791544
- Testing
- AVE1642, sorafenib, erlotinib
- Where
- France
- Volunteers
- 13 people
- Sponsor
- Sanofi
Myelodysplastic Syndromes
A Study of Oral Clofarabine in Adult Patients With Myelodysplastic Syndromes (MDS)
This study will be used to determine the maximum tolerated dose of oral clofarabine when administered daily for 14 consecutive days repeated every 21 days.
- Trial name
- NCT00750334
- Testing
- clofarabine
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Stargardt Disease
This is a Dose-finding Study Followed by 2-year Extension Study to Evaluate Safety and Tolerability of Tinlarebant in Adolescent Subjects With Stargardt Disease
Stargardt disease 1 (STGD1) is the most prevalent form of juvenile macular degeneration. It is caused by a rare, inherited autosomal recessive trait, leading to severe and irreversible blindness by the first or second decade of…
- Trial name
- NCT05266014
- Testing
- tinlarebant
- Where
- 3 sites in Australia, Taiwan
- Volunteers
- 13 people
- Sponsor
- RBP4 Pty Ltd
Influenza
Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above
In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3…
- Trial name
- NCT02126761
- Testing
- Adjuvanted, trivalent subunit influenza vaccine, Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine, Antigen level modified adjuvanted, trivalent subunit influenza vaccine
- Where
- Germany
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Seqirus
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
Respiratory Tract Infections
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in…
- Trial name
- NCT03373903
- Testing
- BEZ235, BEZ235 plus everolimus (RAD001)
- Where
- United States
- Volunteers
- 652 people, healthy volunteers welcome
- Sponsor
- Restorbio Inc.
Advanced Solid Tumors, Metastatic Breast Cancer
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Renal Cell Carcinoma
- Trial name
- NCT01482156
- Testing
- RAD001 + BEZ235
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects
A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects
The objectives of this study are to evaluate the safety and tolerability of a single and multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the pharmacodynamics of ASP3325 orally administered…
- Trial name
- NCT02500953
- Testing
- ASP3325
- Where
- Japan
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Polyarticular Course Juvenile Idiopathic Arthritis
Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis
The present study has been designed in order to evaluate the efficacy and safety of two doses of Givinostat in subjects with polyarticular course JIA Givinostat ready-to-use suspension especially intended for paediatric…
- Trial name
- NCT01261624
- Testing
- Givinostat
- Where
- 13 sites in Belgium, Czechia and 5 more
- Volunteers
- 16 people
- Sponsor
- Italfarmaco
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
Acute Gout
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine.
- Trial name
- NCT00798369
- Testing
- Canakinumab, Triamcinolone acetonide
- Where
- 75 sites in United States, Argentina and 9 more
- Volunteers
- 200 people
- Sponsor
- Novartis
BAG3 Mutation Associated Dilated Cardiomyopathy
ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy
This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM.
- Trial name
- DCMRestore (NCT07218887)
- Testing
- ALXN2350
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 6 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Oral Squamous Cell Carcinoma
Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
Up to 31 subjects diagnosed with oral squamous cell carcinoma received one application of a permeation enhancer 3 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of the 4 treatment visits.
- Trial name
- PRV111 (NCT03502148)
- Testing
- PRV111 (Cisplatin Transmucosal System)
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Privo Technologies
Rhinitis, Rhinoconjunctivitis
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
- Trial name
- MG56 (NCT02654223)
- Testing
- MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous, MG56 Mannosylated 3000 subcutaneous
- Where
- 12 sites in Spain
- Volunteers
- 180 people
- Sponsor
- Inmunotek S.L.
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