Clinical trials: System Safety
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers…
- Trial name
- NCT03537508
- Testing
- MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine
- Where
- 70 sites in United States, Puerto Rico
- Volunteers
- 2,627 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Atherosclerosis, Carotid Atherosclerosis
Visualization of Carotid Atherosclerosis by 68Ga-MSA
Until now, no specific atherosclerosis-targeting agent labeled with positron emitter is not yet available. Investigators developed neomannosyl human serum albumin(MSA) for the terminal mannose residues of MSA binding with the…
- Conditions
- Atherosclerosis, Carotid Atherosclerosis, Noninvasive Imaging of Atherosclerosis
- Trial name
- NCT01893489
- Testing
- 68Gallium-MSA
- Where
- 2 sites in South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Korea University
Asthma
The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose.
- Trial name
- NCT00453791
- Testing
- GW805858
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
Moderate or Severe Submental Fullness
Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.
- Trial name
- AYP-101 (NCT03982225)
- Testing
- Polyene phosphatidylcholine injection
- Where
- 4 sites in South Korea
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- AMIpharm Co., Ltd.
Diabetes Mellitus, Type 2
Renal Impairment in Type 2 Diabetic Subjects
The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with…
- Trial name
- NCT00554450
- Testing
- Dapagliflozin
- Where
- 4 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02199691
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 1,715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Contraception
To Investigate the Pharmacological Effects, Drug Blood Levels and Safety of an Intrauterine System Releasing the Study Drug BAY1007626 in Comparison to Mirena and Jaydess in Healthy Young Women Treated for 90 Days to Determine the Drug Dose for Further Development
Investigation of pharmacological effects, drug blood levels and safety of an intrauterine system releasing the study drug BAY1007626 in comparison to Mirena and Jaydess in healthy young women treated for 90 days to determine the…
- Trial name
- NCT02490774
- Testing
- BAY1007626, Jaydess, Mirena
- Where
- 7 sites in Germany, Netherlands and 1 more
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- Bayer
Irritable Bowel Syndrome
Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety…
- Trial name
- NCT01633723
- Testing
- DA-6886
- Where
- South Korea
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Asthma
A Clinical Trial of TQC2938 Injection in Healthy Adult Subjects
The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic…
- Trial name
- NCT06449859
- Testing
- TQC2938 Injection
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Painful Lumbar Radiculopathy, Healthy
Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)
The primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in…
- Trial name
- NCT01842126
- Testing
- BG00010 IV, BG00010 SC
- Where
- Netherlands
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy, Primary Immune Thrombocytopenia
A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP).
- Conditions
- Healthy, Primary Immune Thrombocytopenia, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Trial name
- NCT03275740
- Testing
- PF-06755347 intravenous healthy participant, PF-06755347 subcutaneous healthy participant, PF-06755347 subcutaneous ITP
- Where
- 6 sites in United States, Belgium and 3 more
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteer, Urea Cycle Disorder
Safety and Tolerability of SYNB1020-CP-001
A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics
- Trial name
- SYNB1020CP001 (NCT03179878)
- Testing
- SYNB1020
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Synlogic
Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B
Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers).
- Conditions
- Meningococcal Meningitis, Serogroup A, Meningococcal Meningitis, Serogroup B, Meningococcal Meningitis, Serogroup C, Meningococcal Meningitis, Serogroup Y
- Trial name
- MenOccy (NCT00962624)
- Testing
- meningococcal B vaccine & meningococcal ACYW conjugate vaccine
- Where
- United Kingdom
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Prof. Elizabeth Miller
Orthostatic Hypotension, Spinal Cord Injury
Safety and Efficacy of L-NAME and Midodrine to Increase MAP
After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects…
- Trial name
- NCT00835224
- Testing
- L-NAME, Midodrine
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Gastroparesis
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
Motilin is a peptide whose action is controlled by motilin receptors located in the gut. Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying of food and fluid from the stomach).
- Trial name
- NCT00562848
- Testing
- GSK962040
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Subcutaneous Adipose Tissue
Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.
- Trial name
- NCT01853397
- Testing
- Liposonix System (Model 2)
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Solta Medical
Cervical Cancer, Human Papillomavirus Infection
Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS) Asian/Asian American Women Supplement
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix.
- Trial name
- NCT06577220
- Testing
- Telephone Recall, Mailed HPV Self-Sampling Kit, Patient Navigation
- Where
- United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Cutis Laxa
Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck
The purpose of this study is to demonstrate superiority of treatment with the Ulthera System compared to untreated control for the improvement of skin laxity of the lower face, submental area and neck and to demonstrate the…
- Trial name
- NCT07614997
- Testing
- Ulthera System
- Where
- 7 sites in China
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.