Clinical trials: Safety and Tolerability
Healthy Volunteer, Pharmacokinetic Study
A Study of Ralinepag in Healthy Chinese Adult Subjects
A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese Subjects.
- Trial name
- NCT04613999
- Testing
- Ralinepag
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Everstar Medicines (Shanghai) Limited
Scarring
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal…
- Trial name
- NCT03036306
- Testing
- SCX-001
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ScarX Corp
Bowel Preparation
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy.
- Trial name
- CLEAR PREP (NCT02386449)
- Testing
- sodium picosulfate, magnesium oxide and citric acid (Picoprep®), mannitol, Bisacodyl
- Where
- Brazil
- Volunteers
- 184 people
- Sponsor
- Ferring Pharmaceuticals
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Nonexudative Age-related Macular Degeneration
Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration
Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.
- Trial name
- NCT01922128
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- MacuCLEAR, Inc.
Pulmonary Arterial Hypertension
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult…
- Trial name
- NCT04903730
- Testing
- AER-901 Solution for Nebulization
- Where
- Australia
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Aerami Therapeutics
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
High Grade Glioma
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma…
- Trial name
- NCT05362409
- Testing
- 5 Aminolevulinic Acid, CV01-delivered ultrasound
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Alpheus Medical, Inc.
Healthy
A Pharmacokinetic, Pharmacodynamic, Safety Study With AOP LDLA202, ONO LDL50 and Esmolol in Healthy Volunteers
The study consists of a Pilot Phase (to assess safety and the local tolerability of highest AOP LDLA202 dose versus placebo) and a Main Treatment Phase (to compare PK, PD and safety and tolerability of AOP LDLA202, ONO LDL50 and…
- Trial name
- NCT01652898
- Testing
- LDLA202, ONO LDL50, Esmolol hydrochloride
- Where
- Czechia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AOP Orphan Pharmaceuticals AG
Diabetes Mellitus, Type 2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 days in patients with type 2 diabetes.
- Trial name
- NCT02211963
- Testing
- BI 44847
- Volunteers
- 48 people
- Sponsor
- Boehringer Ingelheim
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
Chronic Obstructive Pulmonary Disease
A Clinical Trial of TQC3721 Suspension for Inhalation
To evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3721 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy TQC3721…
- Trial name
- NCT05051930
- Testing
- TQC3721 suspension for inhalation
- Where
- China
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Relapsed or Refractory Multiple Myeloma
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed…
- Trial name
- NCT06500507
- Testing
- QLS4131 Injection
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency
Phase 4, Double-blind Study Evaluating the Response on Computed Tomography (CT) Lung Density Decline Rates of Respreeza / Zemaira Weekly for 3 Years in Adults With alpha1 Antitrypsin Deficiency (AATD)
This is a multicenter, parallel-group, double-blind, randomized phase 4 study designed to identify the optimal dose of CE1226 (2 active doses) to slow disease progression as assessed by reduced rates of annual lung density…
- Conditions
- Alpha1 Antitrypsin Deficiency, Alpha1-Proteinase Inhibitor Deficiency, Emphysema
- Trial name
- NCT07326592
- Testing
- CE1226
- Where
- 2 sites in Denmark
- Volunteers
- 270 people
- Sponsor
- CSL Behring
HCV
TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of three different doses of TMC435350 compared to placebo in healthy Japanese males.
- Trial name
- NCT00752544
- Testing
- TMC435350
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Early-onset Parkinson's Disease
The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease
The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment.
- Trial name
- NCT06608355
- Testing
- Human Dopaminergic Progenitor Cells
- Where
- China
- Volunteers
- 6 people
- Sponsor
- iRegene Therapeutics Co., Ltd.
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
Metastatic Colorectal Cancer
A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in…
- Trial name
- NCT02453464
- Testing
- Sevacizumab, Irinotecan, 5-FU
- Where
- 3 sites in China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Mild Dyslipidemia
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
- Trial name
- NCT01105598
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Esperion Therapeutics, Inc.