Clinical trials: Safety and Tolerability
Dyslipidemias, Non-Alcoholic Fatty Liver Disease
A Study of LY3885125 in Participants With Dyslipidemia or Non-Alcoholic Fatty Liver Disease (NAFLD)
The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with…
- Trial name
- NCT06007651
- Testing
- LY3885125
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Eli Lilly and Company
Schizophrenia
A Study of Safety and Tolerability in Subjects With Schizophrenia
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical…
- Trial name
- NCT01354353
- Testing
- LY2140023, Aripiprazole
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Denovo Biopharma LLC
Parkinson's Disease
Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations.
- Trial name
- NCT00505622
- Testing
- Perampanel
- Where
- France
- Volunteers
- 328 people
- Sponsor
- Eisai Limited
Prostate Cancer, Bone Metastases
A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer
This study is intended to test an experimental new drug called, EMD 525797 (Study Drug). This drug is not yet approved for sale and has only been tested in a small number of people to date (prior to this study starting another…
- Trial name
- NCT00958477
- Testing
- EMD 525797
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 26 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Alzheimer Disease, Alzheimer Disease (AD)
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60.
- Conditions
- Alzheimer Disease, Alzheimer Disease (AD), Alzheimers Disease Prevention
- Trial name
- NCT06831812
- Testing
- AV-1959R (Abeta vaccine)
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Nuravax, Inc.
Advanced Solid Tumor
Study to Assess AFM24 in Advanced Solid Cancers
AFM24-101 is a first in human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has…
- Trial name
- NCT04259450
- Testing
- 14 mg AFM24, 40 mg AFM24, 80 mg AFM24
- Where
- 13 sites in United States, Germany and 3 more
- Volunteers
- 85 people
- Sponsor
- Affimed GmbH
Progressive Supranuclear Palsy
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
- Trial name
- NCT02985879
- Testing
- ABBV-8E12
- Where
- 66 sites in United States, Australia and 6 more
- Volunteers
- 378 people
- Sponsor
- AbbVie
Lung Cancer, Solid Tumor
Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
The purpose of this study will be to evaluate the safety, tolerability, and pharmacological activity of pemigatinib in subjects with advanced malignancies.
- Conditions
- Lung Cancer, Solid Tumor, Gastric Cancer, Urothelial Cancer
- Trial name
- NCT02393248
- Testing
- Pemigatinib, Gemcitabine, Pembrolizumab
- Where
- 20 sites in United States, Denmark
- Volunteers
- 201 people
- Sponsor
- Incyte Corporation
Alzheimer's Disease
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672.
- Trial name
- NCT00490568
- Testing
- Rosiglitazone XR
- Where
- 272 sites in United States, Argentina and 27 more
- Volunteers
- 1,461 people
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent…
- Trial name
- NCT01200368
- Testing
- 13-valent pneumococcal conjugate vaccine (13vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), 7-valent pneumococcal conjugate vaccine (7vPnC)
- Where
- 32 sites in Japan
- Volunteers
- 551 people
- Sponsor
- Pfizer
Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers
- Trial name
- NCT02303574
- Testing
- AZD7986, oral solution, 1 to 50 mg/mL
- Where
- United Kingdom
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Irritable Bowel Syndrome
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).
- Trial name
- CAPTIVATE (NCT04043455)
- Testing
- Olorinab
- Where
- 69 sites in United States
- Volunteers
- 273 people
- Sponsor
- Arena Pharmaceuticals
Chronic Spinal Cord Injury
AXER-204 in Participants With Chronic Spinal Cord Injury
This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of AXER-204 administered by lumbar puncture and slow bolus infusion.
- Trial name
- RESET (NCT03989440)
- Testing
- AXER-204
- Where
- 6 sites in United States
- Volunteers
- 52 people
- Sponsor
- ReNetX Bio, Inc.
Leukemia, Myeloid, Acute
A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
- Trial name
- NCT05424380
- Testing
- GSK3745417
- Where
- 10 sites in Canada, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- GlaxoSmithKline
Non-small Cell Lung Cancer, Pancreatic Cancer
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite
- Trial name
- PROACC-1 (NCT05546476)
- Testing
- ponsegromab
- Where
- 78 sites in United States, Australia and 9 more
- Volunteers
- 187 people
- Sponsor
- Pfizer
Healthy
Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.
- Trial name
- NCT04863417
- Testing
- PF-07038124 or vehicle
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Zika Virus
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
- Trial name
- NCT03014089
- Testing
- mRNA-1325
- Where
- 3 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Schizophrenia
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
- Trial name
- NCT02634320
- Testing
- Aripiprazole Lauroxil
- Where
- 18 sites in United States
- Volunteers
- 51 people
- Sponsor
- Alkermes, Inc.
Postmenopausal Osteoporosis (PMO)
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
- Trial name
- NCT01992159
- Testing
- Romosozumab
- Where
- 27 sites in Japan
- Volunteers
- 252 people
- Sponsor
- Amgen
Non-alcoholic Fatty Liver Disease
6-week Safety and PD Study in Adults With NAFLD
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH…
- Trial name
- NCT03256526
- Testing
- PF-06835919 Low Dose, PF-06835919 High Dose
- Where
- 9 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
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