Clinical trials: Safety and Tolerability
Muscular Dystrophy, Oculopharyngeal (OPMD)
Continuation Protocol to Protocol BBCO-001
This will be a multi-center, randomized withdrawal, open-label, non-treatment concurrent control, parallel group study. Patients completing protocol BBCO-001 will be offered the opportunity to enter into this 12-month randomized…
- Trial name
- HOPEMD (NCT02328482)
- Testing
- Tehalose 30gr
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- Bioblast Pharma Ltd.
Healthy Volunteers
Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994
This is a double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study will be conducted in 2 parts: a single ascending dose (SAD) part, followed by a multiple ascending dose (MAD) part.
- Trial name
- NCT03395249
- Testing
- SPR994, Orapenem®
- Where
- Australia
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Spero Therapeutics
Breast Cancer
A Study to Assess the Effects of MK0822 in Reducing the Risk of Bone Metastasis in Women With Breast Cancer (0822-029)
The purpose of this study is to test MK0822 on reducing the risk of bone metastasis in women with breast cancer.
- Trial name
- NCT00692458
- Testing
- Comparator: odanacatib
- Sponsor
- Merck Sharp & Dohme LLC
Pulmonary Disease, Chronic Obstructive
Pharmacokinetic Study in Elderly Patients With Chronic Obstructive Bronchitis (COPD)
Study to evaluate the pharmacokinetics of tiotropium following 14 days of administration (18µg once per day) in elderly COPD patients.
- Trial name
- NCT02172326
- Testing
- Tiotropium inhalation capsules for oral inhalation
- Volunteers
- 29 people
- Sponsor
- Boehringer Ingelheim
Hematologic Neoplasms
A Phase 1/2 Study of KK2430 in Participants With Hematologic Neoplasms
KK2430 ("Study Drug") as a potential treatment for people with Hematologic Neoplasms. KK2430 is an experimental drug; it has not been approved for the treatment of any disease by health authorities such as United States Food and…
- Trial name
- NCT07629726
- Testing
- KK2430
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy
Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers.
SANTANA Study is a phase 1, prospective, monocentric, open-label clinical trial involving healthy adult volunteers, with the objective to evaluate the safety and tolerability of the compressor nebulization of autologous…
- Trial name
- SANTANA (NCT04645485)
- Testing
- Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).
- Where
- United Arab Emirates
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Abu Dhabi Stem Cells Center
Hepatitis C
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants.
- Trial name
- NCT00998985
- Testing
- Grazoprevir
- Volunteers
- 91 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278
The purpose of this study is to examine the safety, local tolerability and pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of a…
- Trial name
- NCT01031589
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Advanced Solid Tumor
Repeat Intravenous Infusions of B4T2-001 CAR-T Without Lymphodepleting Chemotherapy for Solid Tumors
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of autologous B4T2-001 CAR-T in subjects with advanced solid tumors including but not…
- Trial name
- NCT06072989
- Testing
- B4T2-001 autologous CAR-T
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai East Hospital
Neuropathic Pain From Lumbosacral Radiculopathy
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR).
- Trial name
- RELAY-1 Extend (NCT02957617)
- Testing
- BIIB074
- Where
- 51 sites in Austria, Belgium and 12 more
- Volunteers
- 302 people
- Sponsor
- Biogen
Healthy
Single Ascending Dose Study of MYK-461 in Healthy Volunteers
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02356289
- Testing
- MYK-461
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- MyoKardia, Inc.
Renal Impairment
Pharmacokinetics of 10 mg Teduglutide in Subjects With Renal Impairment Compared to Healthy Subjects With Normal Renal Function
To evaluate the effect of renal impairment on the pharmacokinetics (PK) of teduglutide following subcutaneous (SC) administration of 10 mg teduglutide.
- Trial name
- NCT01028768
- Testing
- Teduglutide
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- Nycomed
Hypercholesterolemia
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to…
- Trial name
- NCT02476006
- Testing
- ALIROCUMAB SAR236553 (REGN727), ezetimibe, atorvastatin
- Where
- 153 sites in Austria, Belgium and 14 more
- Volunteers
- 998 people
- Sponsor
- Sanofi
Parkinson Disease, Intestinal Bacteria Flora Disturbance
Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study
This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease.
- Conditions
- Parkinson Disease, Intestinal Bacteria Flora Disturbance, Dietary Modification
- Trial name
- NCT03667404
- Testing
- Resistant maltodextrin, maltodextrin
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
HIV Infections
A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity
This study is designed to investigate the safety, tolerability and PK of VH4524184 (GSK4524184) and the potential of VH4524184 to inhibit or induce CYP3A activity in healthy participants.
- Trial name
- NCT05631704
- Testing
- VH4524184, Midazolam
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Pharmacokinetic Study of Peginterferon Beta-1a in Japanese and Caucasian Adult Healthy Participants.
The primary objective of this study is to characterise the pharmacokinetics (PK) of BIIB017 (Peginterferon Beta-1a) administered as a single 125 μg subcutaneous (SC) dose in Japanese and Caucasian adult healthy participants.
- Trial name
- NCT01978652
- Testing
- Peginterferon Beta-1a
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Biogen
Advanced Unresectable Solid Tumors
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable…
- Trial name
- NCT04894825
- Testing
- M108
- Where
- China
- Volunteers
- 152 people
- Sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
Allergic Rhinitis, Allergic Rhinoconjunctivitis
SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding
The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo.
- Trial name
- NCT01639768
- Testing
- SUBLIVAC FIX Birch
- Where
- 20 sites in Czechia, Germany and 1 more
- Volunteers
- 270 people
- Sponsor
- HAL Allergy
NSCLC, Other Solid Tumors
A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where…
- Trial name
- NCT05332574
- Testing
- GB263T
- Where
- 4 sites in Australia
- Volunteers
- 120 people
- Sponsor
- Genor Biopharma Co., Ltd.
Depressive Disorder, Major
A Safety, Efficacy and Tolerability Study of SEP-225289
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
- Trial name
- NCT00584974
- Testing
- SEP-225289, Venlafaxine
- Where
- 51 sites in United States
- Volunteers
- 523 people
- Sponsor
- Sumitomo Pharma America, Inc.