Clinical trials: System Safety
Asthma
Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®
The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized…
- Trial name
- NCT05898984
- Testing
- Test product (T):CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI, Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI, Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg)
- Where
- Belgium
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies
To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.
- Trial name
- RECIPE (NCT03864185)
- Testing
- Rituximab (genetical recombination)
- Where
- 4 sites in Japan
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Nagoya University
Alzheimer Disease
A Phase 1 Trial to Assess Safety, Tolerability and Pharmacokinetics of ALIA-1758 in Healthy Participants
This is a Phase 1, first in human (FIH), double-blind, placebo-controlled, single ascending dose (SAD) trial to assess the safety, tolerability, and pharmacokinetics (PK) of intravenously (IV) or subcutaneously (SC) injected…
- Trial name
- NCT06406348
- Testing
- ALIA-1758
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- AbbVie
Diabetes Mellitus, Type 2
A Study of the Efficacy and Safety of Supaglutide in Healthy Participants
This study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese healthy subjects.
- Trial name
- NCT03745885
- Testing
- Supaglutide injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Rheumatoid Arthritis
A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects.
- Trial name
- NCT05380934
- Testing
- TQH3821 tablets, Methotrexate tablets
- Where
- China
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Encephalitis
A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants
Japanese encephalitis (JE) is an acute viral zoonotic disease. Neurologic manifestations of the disease range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders.
- Trial name
- NCT02367664
- Testing
- 0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine, 0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)
- Where
- China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
HIV Infections
A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection.
- Trial name
- NCT00000798
- Testing
- HIV-1 Peptide Vaccine, Microparticulate Monovalent
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Muscular Atrophy
A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.
- Trial name
- NCT00952887
- Testing
- ACE-031
- Where
- 2 sites in Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Hepatitis A
Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine
A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A…
- Trial name
- NCT00534885
- Testing
- Healive® Lot 1, Healive® Lot 2, Healive® Lot 3
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Meningococcal Disease, Meningococcal Meningitis
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers…
- Trial name
- NCT01423084
- Testing
- Serogroup B meningococcal vaccine
- Where
- 13 sites in Australia, Canada
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02919293
- Testing
- Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free), Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
- Where
- China
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Hepatitis C
Comparison of Safety and Resulting Blood Level Profiles After Administration of a New Boceprevir Tablet Versus Its Current Capsule Formulation for Treatment of Chronic Hepatitis C (P06992)(COMPLETED)
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule…
- Trial name
- NCT01181804
- Testing
- boceprevir
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Tobacco Use Cessation
Ask Advise Connect (AAC) Harris Heath CPRIT
The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas…
- Trial name
- NCT01788787
- Testing
- Quitline-Delivered Proactive Telephone Counseling, Follow-Up Phone Call, Smoking Cessation Training
- Where
- United States
- Volunteers
- 5,212 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Asthma
A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)
The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB) in healthy and asthmatic participants, and…
- Trial name
- NCT01866306
- Testing
- RV16UB, LABA
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Major Depressive Disorder, Excessive Sleepiness
Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers
To evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of GATE-101 in normal human volunteers
- Trial name
- NCT04618263
- Testing
- GATE-101
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Syndeio Biosciences, Inc
Carpal Tunnel Syndrome
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome
Interventional study to evaluate efficacy and safety of an active splint.
- Trial name
- NCT03810326
- Testing
- CTR device (tradename named Xtend)
- Where
- Israel
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Yuinvent Innovations Ltd.
Alzheimer's Disease
Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
- Trial name
- NCT01467726
- Testing
- Velusetrag
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Alfasigma S.p.A.
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Epilepsy
A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers
Randomized, double-blind, placebo-controlled, sequential multiple ascending dose study to determine a maximum tolerated dose
- Trial name
- NCT01879332
- Testing
- BIA 2-093 3000 mg once daily, BIA 2-093 3600 mg once daily
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Drug Resistant Epilepsy
Role of the Gut Microbiota in Pediatric Epilepsy
Nearly a third of children with epilepsy are refractory to pharmacotherapy. The ketogenic diet (KD) is a highly effective alternative therapy reducing seizure frequency by 50% in more than half of treated children.
- Trial name
- EPBiome (NCT04705298)
- Testing
- Prebiotic
- Where
- 2 sites in Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- British Columbia Children's Hospital
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