Clinical trials: Dose-Finding Study
- Condition Dose-Finding Study
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Enterovirus Infections
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2…
- Trial name
- NCT03268083
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein ] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
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
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
URTICARIA
Efficacy of Rupatadine 5, 10 and 20 mg in Chronic Idiopathic Urticaria
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with…
- Trial name
- NCT00199238
- Testing
- Rupatadine Fumarate
- Where
- France
- Volunteers
- 248 people
- Sponsor
- J. Uriach and Company
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
Respiratory Syncytial Virus Infection
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
The primary objectives of the study were: To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
- Trial name
- VAD00001 (NCT04491877)
- Testing
- RSV vaccine formulation 1, RSV vaccine formulation 2
- Where
- 29 sites in United States, Chile and 1 more
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway alterations.
- Conditions
- Ovarian Neoplasms, Non-Small-Cell Lung Carcinoma, Melanoma, Other Solid Tumors
- Trial name
- NCT02711345
- Testing
- LTT462
- Where
- 7 sites in United States, Germany and 4 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Idiopathic Short Stature
A Study (Phase 1b/2) of GenSci134 in Children With Idiopathic Short Stature (ISS)
This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK/PD profile, and…
- Trial name
- NCT07450053
- Testing
- GenSci134 Injection, Recombinant Human Growth Hormone Injection(Norditropin® FlexPro®)
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Prader-Willi Syndrome
Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
- Trial name
- PWS (NCT05198362)
- Testing
- Tesomet
- Where
- United States
- Sponsor
- Saniona
Asthma
Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma
This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.
- Trial name
- NCT00936624
- Testing
- SOTB07, montelukast
- Where
- South Korea
- Volunteers
- 245 people
- Sponsor
- SK Chemicals Co., Ltd.
Short Stature Children Born Small for Gestational Age (SGA)
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already…
- Trial name
- NCT03878446
- Testing
- Somapacitan, Norditropin®
- Where
- 95 sites in United States, Algeria and 21 more
- Volunteers
- 62 people
- Sponsor
- Novo Nordisk A/S
Juvenile Idiopathic Arthritis
An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)
Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in participants aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate…
- Trial name
- SKYPP (NCT02776735)
- Testing
- Sarilumab
- Where
- 30 sites in United States, Argentina and 13 more
- Volunteers
- 102 people
- Sponsor
- Sanofi
Chronic Spontaneous Urticaria
Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)
This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria (CSU).
- Trial name
- NCT03437278
- Testing
- Ligelizumab
- Where
- 20 sites in Argentina, Belgium and 8 more
- Volunteers
- 49 people
- Sponsor
- Novartis Pharmaceuticals
Crohn Disease
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
The purpose of this study to examine the safety and efficacy of OPC-6535 and determine its optimal dose by once-daily oral administration at 0, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic…
- Trial name
- NCT00317369
- Testing
- OPC-6535(Tetomilast)
- Where
- 8 sites in Japan
- Volunteers
- 29 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Pediatric Hypertension
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive…
- Trial name
- NCT00244634
- Testing
- candsartan cilexetil
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 238 people
- Sponsor
- AstraZeneca
Acute Graft Versus Host Disease
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while…
- Trial name
- NCT00032773
- Testing
- pentostatin for injection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Juvenile Idiopathic Arthritis
Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis
Primary Objective of the study: the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at…
- Trial name
- NCT01557452
- Testing
- Givinostat
- Where
- Czechia
- Volunteers
- 1 people
- Sponsor
- Italfarmaco
Tick-borne Encephalitis
Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 1 to 6 Years.
The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine in healthy children aged 1 to 6 years.
- Trial name
- NCT00161772
- Testing
- Tick-borne Encephalitis Vaccine
- Where
- 23 sites in Austria, Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer