Clinical trials: Safety and Tolerability
- Condition Safety and Tolerability
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Neuroendocrine Tumors
Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs
The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors…
- Trial name
- NCT02592707
- Testing
- Satoreotide tetraxetan, Amino acid solution, Antiemetic
- Where
- 9 sites in United States, Australia and 6 more
- Volunteers
- 40 people
- Sponsor
- Ipsen
Solid Tumors
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
- Trial name
- NCT04642365
- Testing
- RO7296682, Atezolizumab
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Arthroplasty, Replacement, Hip, Thrombosis
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the…
- Trial name
- NCT00107900
- Testing
- DU-176b
- Where
- United States
- Volunteers
- 606 people
- Sponsor
- Daiichi Sankyo
Schizophrenia, Schizoaffective Disorder
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Central Nervous System Diseases
- Trial name
- NCT01556763
- Testing
- EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day), Antipsychotic therapy
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- FORUM Pharmaceuticals Inc
Pulmonary Fibrosis
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.
- Trial name
- NCT01170065
- Testing
- BIBF 1120
- Where
- 57 sites in Argentina, Australia and 19 more
- Volunteers
- 198 people
- Sponsor
- Boehringer Ingelheim
Neoplasms, Carcinoma, Non-Small-Cell Lung
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.
- Conditions
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03948763
- Testing
- V941, Pembrolizumab
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Depression
Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.
- Trial name
- NCT00610649
- Testing
- MK-8777
- Volunteers
- 54 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell
Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST) [STAR-TOR]
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent /…
- Conditions
- Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell, Gastrointestinal Stroma Tumors
- Trial name
- STAR-TOR (NCT00700258)
- Testing
- Temsirolimus, Sunitinib, Axitinib
- Where
- 77 sites in Germany
- Volunteers
- 1,520 people
- Sponsor
- Pfizer
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Viral Respiratory Tract Infection
Safety and Tolerability of Single and Multiple Doses of Neumifil
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of…
- Trial name
- NCT05093530
- Testing
- Neumifil
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pneumagen Ltd.
Hyperphosphatemia, End-stage Renal Disease
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
- Trial name
- NCT00648167
- Testing
- ferric citrate
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Keryx Biopharmaceuticals
Meningitis, Meningococcal
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
- Trial name
- NCT00798304
- Testing
- meningococcal B rLP2086 vaccine, Routine age appropriate childhood vaccines
- Where
- 7 sites in Spain
- Volunteers
- 46 people
- Sponsor
- Pfizer
Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis)
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
Study BT200-01 is a first in human (FIH) study in male and female normal human volunteers (NHVs) that uses an Integrated Protocol Design.
- Conditions
- Cerebrovascular Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis), Intracranial Arteriosclerosis
- Trial name
- NCT04103034
- Testing
- BT200, Desmopressin
- Where
- Austria
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Band Therapeutics
Schizophrenia
Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with…
- Trial name
- NCT02203838
- Testing
- RBP-7000
- Where
- 48 sites in United States
- Volunteers
- 500 people
- Sponsor
- Indivior Inc.
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
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.
Parkinson's Disease
An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
- Trial name
- NCT05543252
- Testing
- Minzasolmin (UCB0599)
- Where
- 96 sites in United States, Canada and 7 more
- Volunteers
- 428 people
- Sponsor
- UCB Biopharma SRL
Huntington's Disease
Open Label Extension Study To Investigate Long Term Safety, Tolerability And Efficacy Of Pf-02545920 In Subjects With Huntington's Disease Who Completed Study A8241021
This study is a 12 month open label extension study of PF-02545920 20 mg dosed BID following study A8241021 in subjects with HD. Primary endpoints will be to assess long-term safety and tolerability of 20 mg BID of PF-02545920.
- Trial name
- NCT02342548
- Testing
- 20 mg BID of PF-02545920
- Where
- 50 sites in United States, Canada and 3 more
- Volunteers
- 188 people
- Sponsor
- Pfizer
Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Covid19
Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy…
- Trial name
- COSMIC (NCT05280717)
- Testing
- sotrovimab
- Where
- 10 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
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