Clinical trials: Single Dose
COVID-19
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
This Phase 2b study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of sotrovimab in pediatric participants from birth to less than (<)18 years old with mild-to-moderate Coronavirus Disease-2019…
- Trial name
- COMET-PACE (NCT05124210)
- Testing
- Sotrovimab
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Participants Less Than 12 Months of Age With RSV Illness
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory…
- Trial name
- NCT00435227
- Testing
- Motavizumab
- Where
- 31 sites in United States
- Volunteers
- 12 people
- Sponsor
- MedImmune LLC
Acute Lymphoblastic Leukemia
Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this…
- Trial name
- NCT01471782
- Testing
- Blinatumomab
- Where
- 30 sites in United States, Austria and 5 more
- Volunteers
- 93 people
- Sponsor
- Amgen Research (Munich) GmbH
Exudative Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
Effects of VEGF Trap-Eye (aflibercept) in treatment-naive polypoidal choroidal vasculopathy (PCV) will be evaluated.
- Trial name
- VAULT (NCT01950741)
- Testing
- aflibercept
- Where
- 8 sites in South Korea
- Volunteers
- 48 people
- Sponsor
- Pusan National University Hospital
Emergence Agitation
Propofol in Emergence Agitation
The purpose of the study is to see if a small dose of propofol given intravenously (through a needle into a vein) at the end of anesthesia can make it less likely that children will be agitated as the come out of the anesthetic.
- Trial name
- NCT00535613
- Testing
- Propofol
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of Wisconsin, Madison
Exercise-induced Bronchoconstriction (EIB)
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo).
- Trial name
- NCT00534976
- Testing
- Comparator: montelukast sodium
- Volunteers
- 364 people
- Sponsor
- Organon and Co
Gonorrhea
Zoliflodacin in Uncomplicated Gonorrhoea
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg…
- Trial name
- NCT03959527
- Testing
- zoliflodacin, ceftriaxone, azithromycin
- Where
- 17 sites in United States, Belgium and 3 more
- Volunteers
- 1,011 people
- Sponsor
- Global Antibiotics Research and Development Partnership
RSV Infection
Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in…
- Trial name
- NCT03596801
- Testing
- RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Meningococcal Infections, Meningitis
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
- Trial name
- NCT00862277
- Testing
- Menactra®, Menomune®
- Where
- 20 sites in United States
- Volunteers
- 763 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Systemic Infections
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in children from 3 months of age to <18 years.
- Trial name
- NCT01893346
- Testing
- CAZ-AVI
- Where
- 10 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pfizer
Hookworm
Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children
This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of two regimens of mebendazole in school-aged children.
- Trial name
- NCT03245398
- Testing
- Treatment with one of the two regimens of mebendazole
- Where
- Tanzania
- Volunteers
- 186 people
- Sponsor
- Jennifer Keiser
Allergic Rhinitis, Upper Respiratory Infection
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children
The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to < 18 years.
- Trial name
- NCT00796315
- Testing
- Doxylamine Succinate USP
- Where
- 6 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Procter and Gamble
Chemotherapy-Induced Nausea and Vomiting
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in…
- Trial name
- NCT01442376
- Testing
- Palonosetron, Ondansetron
- Where
- 67 sites in United States, Argentina and 14 more
- Volunteers
- 502 people
- Sponsor
- Helsinn Healthcare SA
HIV Infections
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
First-line antiretroviral regimens are highly efficacious and generally well tolerated. However, as these regimens need to be taken life-long, there is growing concern about long-term toxicities associated with these regimens.
- Trial name
- NCT03682848
- Testing
- DTG + 3TC FDC
- Where
- 8 sites in Kenya, South Africa and 1 more
- Volunteers
- 32 people
- Sponsor
- ViiV Healthcare
Infantile Colic, Infantile Functional Gastrointestinal Disorders
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants.
- Trial name
- NCT00655083
- Testing
- Nepadutant
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Menarini Group
Breast Cancer
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are…
- Trial name
- NCT00259090
- Testing
- Fulvestrant, Anastrazole
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Pain, Fever
Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults.
- Trial name
- NCT00493246
- Testing
- IV Acetaminophen
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Mallinckrodt
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
Hepatitis A, Hepatitis B
Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult
This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline (GSK) Biologicals' Twinrix…
- Trial name
- NCT01000324
- Testing
- Blood sampling, Engerix-B, Havrix
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Spasticity Due to Cerebral Palsy
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild…
- Trial name
- NCT01405950
- Testing
- Zanaflex Capsules
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Acorda Therapeutics