Clinical trials: System Safety
Rhinosinusitis
Laser Assisted Treatment of Chronic Sinusitis With and Without Light Activated Agents
Chronic rhinosinusitis (CRS) is common disorder which affects up to 13% of the US population. CRS affects numerous Quality of Life (QOL) factors including smell, sleep and communication.
- Trial name
- NCT00948519
- Testing
- Laser + ICG, Laser only
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- New York Head & Neck Institute
Medication Errors
Impact of Vendor Systems on Ambulatory Medication Safety
Our objective is to determine the effects of electronic prescribing on medication safety including medication errors, near misses and preventable adverse drug events in the ambulatory setting.
- Trial name
- BWHCERT5E (NCT00773500)
- Testing
- Electronic prescribing
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
FDC, Diabetes Mellitus, Type 2
To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination
To compare the safety and pharmacokinetic properties between the administration of DWP16001 and DWC202213 as an individual drug, and the administration of DWJ1563 as a combination drug.
- Trial name
- NCT05737771
- Testing
- DWC202213, DWJ1563, DWP16001
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Obesity, Type 2 Diabetes
A Three-part First-in-human Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GUB-UCN2 in Healthy Lean and Obese Participants and Participants With T2D
The trial will enroll healthy volunteers and individuals living with obesity, with and without Type 2 Diabetes. The study, with a treatment period of up to 16 weeks in selected cohorts, will investigate GUB-UCN2 as both a…
- Trial name
- NCT07702890
- Testing
- GUB-UCN2
- Where
- Germany
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- Gubra A/S
Hepatitis A, Hepatitis A Virus
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
Hepatitis A virus (HAV) remains a common infection in Thai children. Two HAV vaccines are available: inactivated vaccine (I-HAV, 2 doses) and live-attenuated vaccine (L-HAV, single dose), but neither is included in Thailand's…
- Conditions
- Hepatitis A, Hepatitis A Virus, Vaccine-Preventable Diseases
- Trial name
- HAV-2 (NCT06978621)
- Testing
- Inactivated hepatitis A vaccine (I-HAV)
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chiang Mai University
Neurological Disorder
Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).
- Trial name
- NCT05938452
- Testing
- Glyceryl Tribenzoate
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Forest Hills Lab
Alzheimer Disease, Alzheimer Disease (AD)
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection.
- Conditions
- Alzheimer Disease, Alzheimer Disease (AD), Preclinical Alzheimer's Disease
- Trial name
- DU-PRISM (NCT07142278)
- Testing
- DUVAX 200 µg, DUVAX 400 µg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Nuravax, Inc.
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Obesity
The Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity
The study evaluated the safety and efficacy of the vBloc Therapy delivered by the Maestro Rechargeable System compared to a sham control for the treatment obesity.
- Trial name
- ReCharge (NCT01327976)
- Testing
- vBloc (Active Device)
- Where
- 10 sites in United States, Australia
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- ReShape Lifesciences
Diphtheria, Tetanus
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- Aladdin (NCT04618640)
- Testing
- DTaP-IPV combination vaccine
- Where
- 26 sites in South Korea
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Diabetes Mellitus, Non-Insulin-Dependent, Dyslipidemia
Safety Study of BMS-816336 in Healthy Male Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
- Trial name
- NCT00979368
- Testing
- BMS-816336
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Asthma
To Investigate the Pharmacokinetics and Safety of Fluticasone Furoate (FF)/ Umeclidinium (UMEC) Combination Compared With FF and UMEC Monotherapies in Adult Healthy Volunteers Using a Dry Powder Inhaler (DPI)
This will be a randomized, double-blind, single-dose, three-period balanced crossover study in adult healthy subjects. Each of the 18 subjects will be randomized to receive a treatment sequence consisting of each of the three…
- Trial name
- NCT01725685
- Testing
- FF 400 mcg, UMEC 500 mcg, FF/UMEC 400/500 mcg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis E
A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%.
- Trial name
- NCT02603055
- Testing
- 30μg/0.5ml Hepatitis E vaccine, 30μg/0.5ml Recombinant Hepatitis E vaccine
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia
A Phase III Trial to Evaluate the Efficacy, Immunogenicity and Safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) in Chinese Males
This phase III clinical trial was designed to evaluate the efficacy, immunogenicity and safety of a Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.Coli) manufactured by Xiamen…
- Conditions
- Penile/Perineal /Perianal Intraepithelial Neoplasia, Anal Intraepithelial Neoplasia, Penile/Perianal/Perineal Cancer, Anal Cancer
- Trial name
- NCT06866574
- Testing
- Recombinant Human Papillomavirus 9-Valent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) Vaccine (E.coli), Aluminum Adjuvant
- Where
- 4 sites in China
- Volunteers
- 9,300 people, healthy volunteers welcome
- Sponsor
- Xiamen University
Vaccines, Vaccines Adverse Reaction
A Multifaceted Intervention on Reducing Immunization Errors
The goal of this trial is to reduce the general error related to vaccines and immunizations (composited on secondary endpoint), after 11 moths of folow-up after cluster randomization and stepped wedge on primary care on brazilian…
- Conditions
- Vaccines, Vaccines Adverse Reaction, Vaccine Practice
- Trial name
- THEIA (NCT06745635)
- Testing
- Usual Care, Multifaceted intervention
- Where
- Brazil
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hospital Israelita Albert Einstein
Ulcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately…
- Trial name
- NCT00269438
- Testing
- 5 ASA, enemas, suppositories, corticosteroids
- Where
- 66 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Type 2 Diabetes Mellitus
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
This is a randomized, open-label, single dose, crossover, phase 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
- Trial name
- NCT06492655
- Testing
- CKD-383(Fed), CKD-383(Fasted)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
HIV Infections
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women
This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection in high-risk, HIV-uninfected women.
- Trial name
- NCT02568215
- Testing
- VRC01
- Where
- 21 sites in Botswana, Kenya and 5 more
- Volunteers
- 1,924 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)