Clinical trials: Dose-Finding Study
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)
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
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
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
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.
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
Pediatric Growth Hormone Deficiency
Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
This is a phase II, open label, active-controlled, randomized safety and dose finding study of different MOD-4023 dose levels compared to daily r-hGH therapy in pre-pubertal growth hormone deficient children.
- Trial name
- NCT01592500
- Testing
- MOD-4023, Somatropin
- Where
- 4 sites in Greece, Hungary and 1 more
- Volunteers
- 56 people
- Sponsor
- OPKO Health, Inc.
Asthma
Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.) and fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 88 mcg b.i.d and placebo…
- Trial name
- NCT01397162
- Testing
- Fluticasone propionate, BI 54903
- Where
- 41 sites in United States
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Schistosomiasis, Schistosomiasis Mansoni
Praziquantel in Children Under Age 4
The overall goals of this proposal are to conduct a trial to address the significant gaps with respect to our understanding of best approaches to treatment of children ages 1-4 with intestinal schistosomiasis.
- Conditions
- Schistosomiasis, Schistosomiasis Mansoni, Schistosoma Japonicum Infection
- Trial name
- PIP (NCT03640377)
- Testing
- Praziquantel
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
Cryptococcal Meningitis, HIV Infections
High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans.
- Trial name
- NCT00885703
- Testing
- Fluconazole, Amphotericin B
- Where
- 10 sites in United States, India and 6 more
- Volunteers
- 168 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment…
- Trial name
- NCT02616562
- Testing
- somapacitan, Norditropin® FlexPro® pen
- Where
- 89 sites in United States, Austria and 12 more
- Volunteers
- 76 people
- Sponsor
- Novo Nordisk A/S
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Trial name
- NCT00972816
- Testing
- MF59-eH1N1
- Where
- 35 sites in United States, Mexico
- Volunteers
- 1,357 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV Infections, AIDS
Vitamin D Dose Finding Study
Optimal vitamin D (vit D) concentration and metabolism are essential for normal immune function, growth, muscle, bone, and inflammatory status in children, adolescents and adults with HIV/AIDS.
- Trial name
- NCT01092338
- Testing
- Cholecalciferol (Vit D3)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Children's Hospital of Philadelphia