Clinical trials: Safety and Tolerability
- Condition Safety and Tolerability
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Type 2 Diabetes Mellitus
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus.
- Trial name
- NCT02622113
- Testing
- Canagliflozin (TA-7284), Insulin
- Where
- 7 sites in Japan
- Volunteers
- 139 people
- Sponsor
- Tanabe Pharma Corporation
Spinal Muscular Atrophy
A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS…
- Trial name
- EMBRACE (NCT02462759)
- Testing
- Nusinersen
- Where
- 7 sites in United States, Germany
- Volunteers
- 21 people
- Sponsor
- Biogen
Pulmonary Disease, Chronic Obstructive
Long-term Safety Study for GSK573719/GW642444 in Japanese
The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444 Inhalation Powder 125/25 mcg once-daily.
- Trial name
- DB2115362 (NCT01376388)
- Testing
- GSK573719/GW642444 Inhalation Powder
- Where
- 23 sites in Japan
- Volunteers
- 131 people
- Sponsor
- GlaxoSmithKline
HIV Infections
Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed…
- Trial name
- NCT03446573
- Testing
- DTG + 3TC, TAF based regimen (TBR)
- Where
- 133 sites in United States, Australia and 8 more
- Volunteers
- 743 people
- Sponsor
- ViiV Healthcare
Plague, Pneumonic, Plague
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Phase 2, Randomized, Active-Controlled, Observer-Blinded, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine with CpG 1018® Adjuvant Compared with rF1V Vaccine in Adults 18 to 55 Years of Age
- Conditions
- Plague, Pneumonic, Plague, Vaccine-Preventable Diseases
- Trial name
- NCT05506969
- Testing
- rF1V-1018, rF1V vaccine
- Where
- 6 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Intra-abdominal Infections
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
- Trial name
- NCT03354754
- Testing
- LYS228, Standard of care therapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Acute Schizophrenia
Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
- Trial name
- EQUATOR (NCT01668797)
- Testing
- Brexpiprazole
- Where
- 49 sites in United States, Colombia and 6 more
- Volunteers
- 524 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
SARS-CoV-2 Infection, COVID-19
Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
This was a phase IIa, double-blind, placebo-controlled, randomized trial, designed to compare the safety, tolerability, and antiviral activity of EIDD-2801 (molnupiravir) versus placebo as measured by SARS-CoV-2 viral RNA…
- Trial name
- NCT04405570
- Testing
- Molnupiravir 200 mg, Molnupiravir 400 mg, Molnupiravir 800 mg
- Where
- 10 sites in United States
- Volunteers
- 204 people
- Sponsor
- Ridgeback Biotherapeutics, LP
Clostridium Difficile Associated Disease
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine.
- Trial name
- NCT02117570
- Testing
- Clostridium difficile vaccine
- Where
- 12 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Pfizer
Vaccines, Pneumococcal
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccinations…
- Trial name
- NCT00368966
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7-valent Pneumococcal Conjugate Vaccine
- Where
- 41 sites in Spain
- Volunteers
- 619 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hypertension
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension.
- Trial name
- NCT00686803
- Testing
- PL3994
- Volunteers
- 21 people
- Sponsor
- Palatin Technologies, Inc
Acute Optic Neuritis
BIIB033 In Acute Optic Neuritis (AON)
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral acute optic neuritis (AON).
- Trial name
- NCT01721161
- Testing
- BIIB033 (anti-LINGO-1 mAb)
- Where
- 32 sites in Australia, Belgium and 9 more
- Volunteers
- 82 people
- Sponsor
- Biogen
B-cell Non-Hodgkin Lymphoma
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
This study will evaluate the safety, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with…
- Trial name
- NCT03677141
- Testing
- Mosunetuzumab, Polatuzumab Vedotin, Rituxumab
- Where
- 41 sites in United States, Austria and 4 more
- Volunteers
- 117 people
- Sponsor
- Hoffmann-La Roche
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab
The primary purpose of this study is to assess the safety and tolerability of ociperlimab (BGB-A1217) in combination with tislelizumab (BGB-A317) or rituximab in participants with relapsed or refractory (R/R) diffuse large B cell…
- Trial name
- NCT05267054
- Testing
- Ociperlimab, Tislelizumab, Rituximab
- Where
- 19 sites in China
- Volunteers
- 53 people
- Sponsor
- BeiGene
Pompe Disease
Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease
The main purpose of this study was to determine the safety and tolerability of 3 different doses of duvoglustat (AT2220) in participants affected by Pompe disease.
- Trial name
- NCT00688597
- Testing
- Duvoglustat
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Amicus Therapeutics
Liver Cirrhosis, Hepatic Cirrhosis
A Study of IDN-6556 in Subjects With Liver Cirrhosis
This is a multicenter study to see if treatment with IDN-6556 can help improve the liver function of patients with liver cirrhosis with Model for End-Stage Liver Disease scores between 11-18.
- Trial name
- LC (NCT02230670)
- Testing
- IDN-6556
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Multiple Sclerosis
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS).
- Trial name
- OPTIMUM-LT (NCT03232073)
- Testing
- Ponesimod
- Where
- 148 sites in United States, Belarus and 26 more
- Volunteers
- 877 people
- Sponsor
- Actelion
Influenza, COVID-19
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2.
- Trial name
- NCT06178991
- Testing
- Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine
- Where
- 106 sites in United States
- Volunteers
- 8,795 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Osteoporosis, Postmenopausal
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under…
- Trial name
- NCT02109042
- Testing
- Blosozumab
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy…
- Trial name
- NCT04036227
- Testing
- GS-248
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
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