Clinical trials: Single Dose
Lupus
Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are…
- Trial name
- NCT00299819
- Testing
- MEDI-545, MEDI 545
- Where
- 21 sites in United States, Canada
- Volunteers
- 45 people
- Sponsor
- MedImmune LLC
Pharmacokinetics and Pharmacodynamics
Comparative Clinical Trial of Pharmacokinetics and Pharmacodynamics of Human Insulin Injection
A study of Clinical Trial Comparing Pharmacokinetics and Pharmacodynamics of Human Insulin Injection,in Wuhan Pulmonary Hospital (Wuhan Tuberculosis Prevention and Control Institute).To compare the pharmacokinetic and…
- Trial name
- NCT07608692
- Testing
- Human Insulin Injection（USLIN®R）, Human Insulin Injection（NOVOLIN®R）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Healthy Subjects
Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects
The study will assess the corrected QT (QTc) effects (electrocardiogram [ECG]) of motixafortide (BL-8040) 1.25 mg/kg (therapeutic dose) and 2 mg/kg (supratherapeutic dose) following a single subcutaneous (SC) injection relative…
- Trial name
- NCT05293171
- Testing
- 2 mg/kg BL-8040, 400 mg Moxifloxacin (1x400 mg tablet)
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- BioLineRx, Ltd.
Spinal Cord Injury, Chronic
Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury
This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord…
- Trial name
- NCT03003364
- Testing
- XCEL-UMC-BETA
- Where
- Spain
- Volunteers
- 10 people
- Sponsor
- Banc de Sang i Teixits
Healthy
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects.
- Trial name
- NCT02102932
- Testing
- 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin, 850 mg metformin
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Solid Tumor, Melanoma
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Melanoma, HNSCC, Sarcoma
- Trial name
- NCT04370587
- Testing
- T3011, T3011 + pembrolizumab
- Where
- 9 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- ImmVira Pharma Co. Ltd
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
Aging
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults.
- Trial name
- NCT06367738
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Pulmonary Disease, Chronic Obstructive
A 2 Part Study Examining Doses Of GSK961081 In Healthy Volunteers And Then In COPD Patients
GSK961081 has previously been administered to healthy subjects in a nebulised formulation and the first part of this study which will be conducted in healthy subjects proposes to bridge the change from nebulised to DPI…
- Trial name
- NCT00478738
- Testing
- GSK961081
- Where
- 5 sites in Germany, South Africa
- Volunteers
- 82 people
- Sponsor
- GlaxoSmithKline
Type 1 Diabetes
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
Primary Objective: To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®. Secondary Objective: To assess the safety and tolerability of SAR342434.
- Trial name
- NCT02273258
- Testing
- SAR342434, Insulin Lispro
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Sanofi
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
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD4144
This Phase I, open-label, parallel group study will investigate the single oral dose PK, safety, and tolerability of AZD4144 to male and female participants with mild, moderate, and severe hepatic impairment compared to matched…
- Trial name
- NCT07783308
- Testing
- AZD4144
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Renal Insufficiency
A Study of LY3537982 in Participants With Kidney Problems Compared With Participants With Normal Kidney Function
The purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant.
- Trial name
- NCT07137689
- Testing
- LY3537982
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Infections, Bacterial
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
- Trial name
- NCT03150082
- Testing
- GR37547 tablet, Ciprofloxacin reference tablet
- Where
- South Africa
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cancer, Neoplasms
A Phase I, 2-part (Part 1 Being a Single Dose Escalation and Part 2, a Parallel Group) Study of Toll-like Receptor (TLR4) Agonist (GSK1795091) in Healthy Subjects
This study is an ascending dose first-time-in-human study to determine the safety, tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in healthy subjects.
- Trial name
- NCT02798978
- Testing
- GSK1795091
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hyperuricemia, Gout
Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects
This is a Phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of LC350189 on the QTcF in healthy…
- Conditions
- Hyperuricemia, Gout, Qt Interval, Variation in
- Trial name
- NCT04966325
- Testing
- LC350189 200mg, Moxifloxacin 400mg, LC350189 600mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hepatic Impairment
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment
The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05707390
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Substance Dependence
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before.
- Trial name
- NCT00728897
- Testing
- GSK598809 new formulation, GSK598809 old formulation
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- 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
Hypercholesterolemia
Effect of Alirocumab (SAR236553/REGN727) Administered on Top of Ezetimibe or Fenofibrate on Lipid Profiles in Healthy Subjects
Primary Objective: To assess the pharmacodynamic profile of alirocumab (SAR236553/REGN727) administered either alone or on top of ezetimibe or fenofibrate, based on low-density lipoprotein -cholesterol (LDL-C).
- Trial name
- NCT01723735
- Testing
- Alirocumab, Ezetimibe, Fenofibrate
- Where
- 2 sites in France
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Sanofi
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