Clinical trials: Safety and Tolerability
Healthy Volunteers
A Study of LY3006072 in Healthy Participants
The purpose of this study is to evaluate how safe LY3006072 (study drug) is and whether it causes any side effects. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body…
- Trial name
- NCT01640249
- Testing
- LY3006072
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Follicular B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma Recurrent
Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL
Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory B-Cell NHL or CLL
- Conditions
- Follicular B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma Recurrent, Mantle Cell Lymphoma Refractory, Small Lymphocytic Lymphoma, Relapsed
- Trial name
- NCT05360238
- Testing
- MB-106
- Where
- 6 sites in United States
- Volunteers
- 20 people
- Sponsor
- Mustang Bio
SARS CoV 2 Infection
A Study of EDP-235 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
- Trial name
- NCT05246878
- Testing
- EDP-235
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
HCV Infection
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection.
- Trial name
- NCT01193478
- Testing
- GS-5885
- Where
- 13 sites in United States
- Volunteers
- 71 people
- Sponsor
- Gilead Sciences
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 as a Single Agent in Adult Patients With Advanced Solid Tumors
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and/or recommended Phase 2 dose (RP2D) and assess the DLT of FHND5071.
- Trial name
- NCT05818917
- Testing
- FHND5071
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Advanced Malignant Solid Tumors
N-3C01 Monotherapy and Combination With PD-(L)1 Inhibitors in Advanced Solid Tumors
This Phase I/II study evaluates the safety, tolerability, and efficacy of N-3C01 administered subcutaneously, both as monotherapy and in combination with a PD-(L)1 monoclonal antibody, in patients with advanced solid tumors.
- Trial name
- Solid Tumors (NCT07639450)
- Testing
- N-3C01(Q2W), N-3C01(Q3W), N-3C01
- Where
- 6 sites in Australia, China
- Volunteers
- 114 people
- Sponsor
- Hefei Xinzhu Biological Technology Co., Ltd.
Advanced Solid Tumors, Metastatic Solid Tumors
First-In-Human Study in Subjects With Advanced or Metastatic Solid Malignant Tumors
This study is an open-label, multicenter, first-in-human, Phase I, dose escalation study to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of JSKN003 in subjects with advanced inoperable or metastatic…
- Trial name
- NCT05494918
- Testing
- JSKN003
- Where
- Australia
- Volunteers
- 62 people
- Sponsor
- Alphamab (Australia) Co Pty Ltd.
Sporadic Inclusion Body Myositis
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis
- Trial name
- NCT01423110
- Testing
- BYM338
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Novartis Pharmaceuticals
AD
A Phase I Study of SSGJ-716 in Healthy Adults and Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT07693738
- Testing
- SSGJ-716
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Osteoarthritis, Knee
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain - Dose escalation
- Trial name
- NCT03282149
- Testing
- XT-150
- Where
- Australia
- Volunteers
- 24 people
- Sponsor
- Xalud Therapeutics, Inc.
Recurrent or Metastatic, Advanced Solid Tumors
Safety/Tolerability, PK and Efficacy of IMB071703 Injection in Patients With Advanced Solid Tumors
A Phase Ia Study to Evaluate the Safety/Tolerability, Pharmacokinetics and Preliminary Efficacy of IMB071703 Injection in Subjects with Recurrent or Metastatic，Advanced Solid Tumors
- Trial name
- NCT06292858
- Testing
- IMB071703 injection
- Where
- China
- Volunteers
- 93 people
- Sponsor
- Beijng Immunoah Pharma Tech Co., Ltd.
Advanced Solid Tumor
A Study of EOC237 in Patients With Advanced Solid Tumor
This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.
- Trial name
- NCT05895825
- Testing
- EOC237
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Multiple Sclerosis
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain…
- Trial name
- NCT00053417
- Testing
- 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP), 15 mg fampridine-SR (4-aminopyridine, 4-AP), 20 mg fampridine-SR (4-aminopyridine, 4-AP)
- Where
- 25 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Acorda Therapeutics
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Hereditary Hemorrhagic Telangiectasia
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
The purpose of this study is to: evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-6400 in healthy volunteers evaluate the efficacy, safety, tolerability and PD of…
- Trial name
- InsigHHT (NCT06659640)
- Testing
- ALN-6400
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Cancer, Advanced Solid Malignancies
Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects
The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.
- Trial name
- NCT01340040
- Testing
- MEDI-573
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Mesial Temporal Lobe Epilepsy
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
The main goals of this clinical study are to learn if AMT-260 is safe and tolerable and works to reduce the frequency of seizures in adults with unilateral mesial temporal lobe epilepsy (MTLE).
- Trial name
- GenTLE (NCT06063850)
- Testing
- AAV9-hSyn1-miGRIK2
- Where
- 18 sites in United States
- Volunteers
- 12 people
- Sponsor
- UniQure Biopharma B.V.
Schizophrenia
A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
This is a Phase 2, randomized, double-blinded, placebo-controlled, inpatient study to examine the efficacy, safety, and tolerability profile of KarXT in adult subjects diagnosed with DSM-5 schizophrenia who are in an acute…
- Trial name
- EMERGENT-1 (NCT03697252)
- Testing
- Xanomeline and Trospium Chloride Capsules
- Where
- 12 sites in United States
- Volunteers
- 182 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan