Clinical trials: Phase 1
Healthy
Propolis-Based Solution Application in Extraction Socket Healing
This pilot study evaluated whether a propolis-based topical solution improves soft-tissue healing after tooth extraction. Thirteen patients requiring extraction of two comparable teeth on opposite sides of the mouth were enrolled…
- Trial name
- NCT07665814
- Testing
- Propolis-based topical solution (52% propolis extract, clove oil [Eugenia caryophyllus], and white willow bark [Salix alba] extract), Saline rinse (control)
- Where
- Lebanon
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Saint-Joseph University
Hand, Foot and Mouth Disease, Herpangina
Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design.
- Trial name
- NCT06063057
- Testing
- low dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, medium dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated, high dose Bivalent Enterovirus Vaccine (Vero Cell), Inactivated
- Where
- China
- Volunteers
- 744 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Dilated Cardiomyopathy
A Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM)
This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy.
- Trial name
- NCT06464588
- Testing
- Allogeneic Neonatal mesenchymal stromal cells (nMSCs)
- Where
- 5 sites in United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Respiratory Syncytial Virus, Human Metapneumovirus
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in…
- Trial name
- NCT05743881
- Testing
- mRNA-1345, mRNA-1365, Nimenrix
- Where
- 17 sites in United States, Panama and 1 more
- Volunteers
- 186 people
- Sponsor
- ModernaTX, Inc.
Lymphoma, Non-Hodgkin, Hodgkin Disease
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma
The purpose of this study is to assess the safety, tolerability, drug levels, and preliminary efficacy of relatlimab plus nivolumab in pediatric and young adult participants with recurrent or refractory classical Hodgkin lymphoma…
- Trial name
- RELATIVITY-069 (NCT05255601)
- Testing
- Relatlimab, Nivolumab
- Where
- 51 sites in United States, Australia and 5 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Brain Neoplasms, Primary Malignant
Topotecan by Intracerebral Clysis for Recurrent Primary Malignant Brain Tumors
This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery.
- Trial name
- NCT00308165
- Testing
- Convection-Enhanced Delivery, Topotecan
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Columbia University
Sedation and Analgesia
a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts
This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts
- Trial name
- NCT07669012
- Testing
- Ketamine + propofol, Dexmedetomidine + propofol
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Ain Shams University
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
EBV-Related Hodgkin Lymphoma, EBV-Related Lymphoproliferative Disorder
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment…
- Conditions
- EBV-Related Hodgkin Lymphoma, EBV-Related Lymphoproliferative Disorder, EBV Related Non-Hodgkin's Lymphoma
- Trial name
- CILESTE (NCT04664179)
- Testing
- Dose Level 1A: 2 x 10^7 cells/m2, Dose Level 2A: 6 x 10^7 cells/m2, Dose Level 2B: 6 x 10^7 cells/m2
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- Baylor College of Medicine
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Duchenne Muscular Dystrophy
A Phase 1/2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 351 in Participants With Duchenne Muscular Dystrophy
The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping.
- Trial name
- NCT06280209
- Testing
- BMN 351
- Where
- 7 sites in Italy, Netherlands and 3 more
- Volunteers
- 18 people
- Sponsor
- BioMarin Pharmaceutical
Cutaneous Squamous Cell Carcinoma (CSCC), Renal Transplant
A Study of Tolododekin Alfa (ANK-101) in Renal Allograft Recipients With High Risk Cutaneous Squamous Cell Carcinoma
A study of tolododekin alfa (also known as ANK-101) administered prior to surgery in kidney transplant participants that also have high-risk cutaneous squamous cell carcinoma (CSCC).
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC), Renal Transplant, Solid Tumor, Solid Tumor Cancer
- Trial name
- NCT07100925
- Testing
- tolododekin alfa
- Sponsor
- Ankyra Therapeutics, Inc
Acute Myeloid Leukemia
Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with…
- Trial name
- GO-TAG (NCT05716009)
- Testing
- Dose Escalation -tagraxofusp-erzs, Dose Expansion at RP2D -tagraxofusp-erzs
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Healthy Volunteers
Classroom Break, Cognition, and Fitness in Elementary School Children
The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only…
- Trial name
- NCT06258941
- Testing
- MF-HIIT, HIIT-only, MF-only
- Where
- United States
- Volunteers
- 352 people, healthy volunteers welcome
- Sponsor
- Purdue University
Acute Lymphoblastic Leukemia
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I
The purpose of this study is to test the good and bad effects of the study drugs bortezomib and vorinostat when they are given in combination with chemotherapy commonly used to treat acute lymphoblastic leukemia (ALL) in infants.
- Trial name
- NCT02553460
- Testing
- ITMHA, Dexamethasone, Mitoxantrone
- Where
- 15 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- St. Jude Children's Research Hospital
Shigella Infection
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in…
- Trial name
- NCT07666750
- Testing
- 30μg IP-QSV, 10μg IP-QSV, 2μg IP-QSV
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Pediatric Disorder, Genetic Predisposition
Pharmacogenomic Contributions to Trihexyphenidyl Biotransformation and Response in Children With Dystonic Cerebral Palsy
This study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. The study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this…
- Conditions
- Pediatric Disorder, Genetic Predisposition, Dystonia, Secondary, Dystonia
- Trial name
- TRIKE2 (NCT06554288)
- Testing
- Trihexyphenidyl
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Children's Mercy Hospital Kansas City
Iron Deficiency Anemia in Preterm Neaonates
Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates
Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.
- Trial name
- NCT07667205
- Testing
- Daily oral ferrous ion, Daily oral liposomal iron, Oral liposomal iron every other day
- Where
- Egypt
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Osteopetrosis
Gene-Modified Stem Cell Therapy for Children With Autosomal Recessive Osteopetrosis (ARO)
This is a non-randomized, one-arm, open label, single-center, phase I/II, prospective study, to assess safety, feasibility and efficacy of FT024 in 8 children (Age: ≥ 28 days and ≤ 2 years old, Body weight: ≥ 4 kg) affected by…
- Trial name
- ARO (NCT07665021)
- Testing
- FT024
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione Telethon
T-cell Lymphoma, T-cell Leukemia
CD4CAR for CD4+ Leukemia and Lymphoma
This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma.
- Trial name
- NCT03829540
- Testing
- CD4CAR
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Huda Salman
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