Clinical trials: Single Dose
Poliomyelitis
Safety of Imovax Polio in Chinese Infants and Children
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.
- Trial name
- NCT00258843
- Testing
- Inactivated Poliomyelitis vaccine
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Safety Issues
Safety, Tolerability and Pharmacokinetics of ETD-001 Gel
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are…
- Trial name
- ETD-001 gel (NCT07674862)
- Testing
- Dose 1, dose 2, dose 3
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Etern Therapeutics Wuxi Limited
Ewing's Sarcoma/Soft Tissue Sarcoma, Neuroblastoma
A Combined Study in Pediatric Cancer Patients for Dose Ranging and Efficacy/Safety of Plerixafor Plus Standard Regimens for Mobilization Versus Standard Regimens Alone
This is a multi-site study with plerixafor in pediatric cancer patients. The study will be conducted in 2 stages: Stage 1 is a dose-escalation study.
- Conditions
- Ewing's Sarcoma/Soft Tissue Sarcoma, Neuroblastoma, Brain Tumors
- Trial name
- NCT01288573
- Testing
- plerixafor
- Where
- 27 sites in Belgium, Czechia and 10 more
- Volunteers
- 46 people
- Sponsor
- Genzyme, a Sanofi Company
RSV Infection
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the…
- Trial name
- NCT06866405
- Testing
- RSVpreF
- Where
- 97 sites in United States, Argentina and 2 more
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bacterial Vaginosis
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219
This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.
- Trial name
- NCT02452866
- Testing
- SYM-1219
- Where
- 40 sites in United States
- Volunteers
- 325 people
- Sponsor
- Symbiomix Therapeutics
Sleep Initiation and Maintenance Disorders
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage…
- Trial name
- PKiDs (NCT00913614)
- Testing
- Eplivanserin (SR46349)
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Sanofi
Metastatic Melanoma, Recurrent Melanoma
Aldesleukin With or Without Ziv-Aflibercept in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery.
- Conditions
- Metastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7
- Trial name
- NCT01258855
- Testing
- Aldesleukin, Laboratory Biomarker Analysis, Ziv-Aflibercept
- Where
- 21 sites in United States
- Volunteers
- 84 people
- Sponsor
- National Cancer Institute (NCI)
Haemophilus Influenzae Type b (Hib) Infection
Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China
This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.
- Trial name
- NCT01044316
- Testing
- Haemophilus influenzae type b (Hib) vaccine
- Where
- China
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Severe Hemophilia A
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve…
- Trial name
- NCT06137092
- Testing
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Where
- 5 sites in Iran
- Volunteers
- 50 people
- Sponsor
- AryoGen Pharmed Co.
Healthy
Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers
St. John's Wort is a popular dietary supplement that many patients-including those with epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve stress.
- Trial name
- NCT00006395
- Testing
- St. John's Wort
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Malaria
Treatment of Malaria With Quinine Plus Sulfadoxine-Pyrimethamine
Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment duration of 7 days, and adverse reactions often hamper its adequate use.
- Trial name
- NCT00167739
- Testing
- Quinine plus sulfadoxine-pyrimethamine
- Where
- Gabon
- Volunteers
- 50 people
- Sponsor
- Albert Schweitzer Hospital
Bone Cysts
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone).
- Trial name
- NCT00459641
- Testing
- I-040302, Standard of Care
- Sponsor
- Kuros Biosurgery AG
Venous Thrombosis, Pediatrics
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults.
- Trial name
- NCT01145859
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 36 sites in United States, Australia and 8 more
- Volunteers
- 59 people
- Sponsor
- Bayer
Attention Deficit Disorder With Hyperactivity
Pharmacokinetic and Tolerability Study of NFC-1 in Subjects Aged 6-17 Years With ADHD
This is a open-label, single ascending dose, pharmacokinetic, and tolerability study of NFC-1 in Children and Adolescents (Ages 6-17 Years) with ADHD.
- Trial name
- NCT03006367
- Testing
- NFC-1 100 mg, NFC-1 200 mg, NFC-1 400 mg
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Inherited Retinal Diseases
Safety and Efficacy Study of PUMCH-E101 Injection in Subjects with RDH12 Retinopathy
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E101 injection in subjects with RDH12 retinopathy.
- Trial name
- NCT06749639
- Testing
- PUMCH-E101 Injection（Low dose）, PUMCH-E101 Injection（High dose）
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peking Union Medical College Hospital
Cystic Fibrosis
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis
This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy…
- Trial name
- ABCI (NCT05802264)
- Testing
- ABCI
- Where
- 5 sites in Australia, New Zealand
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Cystetic Medicines, Inc.
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
Safety Study of a Chemokine Receptor (CXCR4) Antagonist in Multiple Myeloma Patients
BKT-140 drug substance is a highly selective chemokine receptor (CXCR4) antagonist, which is developed by Biokine as a novel therapy for Multiple Myeloma (MM, a type of blood cancer).
- Trial name
- NCT01010880
- Testing
- BKT140
- Where
- 2 sites in Israel
- Volunteers
- 16 people
- Sponsor
- Biokine Therapeutics Ltd
Malaria, Plasmodium Infections
Effectiveness of Mass Drug Administration for Reducing Seasonal Malaria Transmission in Zanzibar
The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria…
- Trial name
- MaDrAZ (NCT02721186)
- Testing
- MDA with DHAp and SLD Primaquine
- Where
- Tanzania
- Volunteers
- 22,500 people, healthy volunteers welcome
- Sponsor
- Ulrika Morris
Spastic Cerebral Palsy
INcobotulinumtoxina in ChIldren Upper and Lower Limb sPasticITy (INCIPIT)
Prospective, open-label, non-randomized, single-arm, dose titration, phase II study. The study will consist of three injection cycles. In each, an injection visit is followed by an observation period of 12 to 20 weeks.
- Trial name
- INCIPIT (NCT05340439)
- Testing
- IncobotulinumtoxinA 100 UNT [Xeomin]
- Volunteers
- 30 people
- Sponsor
- Universita di Verona