Clinical trials: Single Dose
Pregnancies at Increased Risk of Preterm Birth
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)
In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS…
- Trial name
- NCT00187382
- Testing
- Multiple vs. single courses of antenatalcorticosteroids
- Where
- Canada
- Volunteers
- 1,858 people
- Sponsor
- Sunnybrook Health Sciences Centre
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Hematologic Malignancies
Study of SLS009 (Formerly GFH009) a Potent Highly Selective CDK9 Inhibitor in Patients With Hematologic Malignancies and High-Risk Newly Diagnosed AML
SLS009 (formerly GFH009) is a potent and highly selective CDK9 inhibitor. In this study the safety, tolerability, and antitumor activity of single agent SLS009 are assessed in two dose escalation groups (Group 1 in patients with…
- Trial name
- NCT04588922
- Testing
- SLS009, venetoclax, azacitidine
- Where
- 32 sites in United States, China
- Volunteers
- 160 people
- Sponsor
- Sellas Life Sciences Group
Recessive Dystrophic Epidermolysis Bullosa
A Phase 1/2 Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Protocol PTR-01-001 is a Phase 1/2 study of PTR-01. The study is divided into an up to 4-week Screening Period, a 10-week Treatment Period and an 8-week Follow-up Period.
- Trial name
- PTR-01-001 (NCT03752905)
- Testing
- PTR-01, Normal saline
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Phoenix Tissue Repair, Inc.
Migraine in Children, Migraine
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
- Trial name
- NCT04537429
- Testing
- Eptinezumab
- Where
- 9 sites in United States
- Volunteers
- 28 people
- Sponsor
- H. Lundbeck A/S
Gram Positive Bacterial Infection
Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected…
- Trial name
- NCT01019395
- Testing
- Daptomycin
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Cutaneous Leishmaniasis
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony…
- Trial name
- GMCSFSbv (NCT00973128)
- Testing
- GMCSF plus Antimony reduced dose, Meglumine antimoniate
- Where
- Brazil
- Volunteers
- 40 people
- Sponsor
- Hospital Universitário Professor Edgard Santos
Type 2 Diabetes
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.
- Trial name
- NCT00730275
- Testing
- Sitagliptin phosphate
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after…
- Trial name
- NCT02172534
- Testing
- Tiotropium bromide low, Tiotropium bromide medium, Tiotropium bromide high
- Volunteers
- 113 people
- Sponsor
- Boehringer Ingelheim
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
Asthma
Dose-Ranging Study of LQ036 Single-Domain Antibody Nebulization Solution in Poorly Controlled Asthma
What is the goal of this study? The goal of this clinical trial is to find out whether the study drug LQ036 (a nebulized solution taken by inhaling through a nebulizer) works to improve lung function and asthma control in people…
- Trial name
- NCT07589439
- Testing
- LQ036
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Shanghai Novamab Biopharmaceuticals Co., Ltd.
Asthma
Safety, Tolerability, and Pharcodynamics of AMG 853 in Adolescents With Asthma
The purpose of this study is to study the safety and tolerability in adolescent and adult subjects with intermittent or mild to moderate persistent asthma.
- Trial name
- NCT01137565
- Testing
- AMG 853
- Volunteers
- 23 people
- Sponsor
- Amgen
Type 1 Diabetes
HCT Cash-Only INcentive to Promote Mealtime Insulin DOSE Engagement
Type 1 Diabetes (T1D) is a serious disease that happens because the body cannot control blood glucose (sugar) levels. People with T1D need insulin shots because their body does not make insulin. Insulin lowers blood sugar levels.
- Trial name
- NCT04621890
- Testing
- LOAN2DOSE and COIN2DOSE
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Children's Mercy Hospital Kansas City
Fabry Disease
Evaluation of the Safety, Tolerability and Efficacy of a Gene Therapy Drug for the Treatment of Pediatric Fabry Disease
This is a single-arm, open label, single-dose clinical study to evaluate the safety, tolerability and efficacy of BBM-F101 injection in the pediatric Fabry disease participants up to 52 weeks after infusion, and the long-term…
- Trial name
- NCT06207552
- Testing
- BBM-F101 injection
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Children's Hospital of Fudan University
Muscular Dystrophies
A Double-blind, Escalating Dose, Randomized, Placebo-controlled Study Assessing PK, Safety, Tolerability in Non-ambulant DMD Subjects
The purpose of this study is investigate the pharmacokinetics, safety and tolerability of single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular dystrophy
- Trial name
- DEMAND I (NCT01128855)
- Testing
- 3 mg/kg GSK2402968, 6 mg/kg GSK2402968, 9 mg/kg GSK2402968
- Where
- 2 sites in United States, France
- Volunteers
- 20 people
- Sponsor
- GlaxoSmithKline
Beta-Thalassemia, Thalassemia
A Safety and Efficacy Study Evaluating CTX001 in Participants With Transfusion-Dependent β-Thalassemia
This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in participans with transfusion-dependent β-thalassemia (TDT).
- Conditions
- Beta-Thalassemia, Thalassemia, Genetic Diseases, Inborn, Hematologic Diseases
- Trial name
- NCT03655678
- Testing
- CTX001
- Where
- 14 sites in United States, Canada and 3 more
- Volunteers
- 59 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pain
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
- Trial name
- NCT01115673
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 540 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Meningococcal Disease
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects 2 Years of Age and Older
A multicenter, single arm, postmarketing surveillance study. This study is a postlicensure requirement of the Philippine Food and Drug Administration (FDA) to provide continued safety evaluation of MenACWY-CRM in Philippine…
- Trial name
- NCT01705379
- Testing
- Novartis Meningococcal ACWY Conjugate Vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Constipation
Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention
The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.
- Trial name
- NCT01674166
- Testing
- prucalopride
- Volunteers
- 38 people
- Sponsor
- Movetis
Advanced Solid Tumor
Study of FCN-011 in Patients With Advanced Solid Tumor（Phase I）and NTRK Fusion Positive Advanced Solid Tumor （Phase II）
A multicenter, open, single-arm phase I dose exploration and phase II extended study was conducted to evaluate the safety, tolerability, pharmacokinetic characteristics, and primary antitumor activity of FCN-011 in patients with…
- Trial name
- NCT04687423
- Testing
- FCN-011
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Fochon Pharmaceuticals, Ltd.