Clinical trials: Safety, and Tolerability
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
Healthy
A Study of LY3463251 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
- Trial name
- NCT03764774
- Testing
- LY3463251
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
ADHD, Attention Deficit Hyperactivity Disorder
Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.
- Trial name
- NCT00585910
- Testing
- Atomoxetine and OROS Methylphenidate
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Massachusetts General Hospital
Patients With Advanced Solid Tumors
BAT7104 in Patients With Advanced Solid Tumours
This is a prospective multi-centre, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT7104 in Patients with Advanced Solid Tumours in Australia.
- Trial name
- NCT05200013
- Testing
- BAT7104
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- Bio-Thera Solutions
Overweight and Obesity
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.
- Trial name
- DA168 (NCT06534320)
- Testing
- DA-302168S
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Hepatic Insufficiency & Healthy Subjects
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
- Trial name
- NCT03465059
- Testing
- Zanubrutinib
- Where
- 2 sites in United States
- Volunteers
- 29 people
- Sponsor
- BeiGene
Schizophrenia
Transcranial Magnetic Stimulation (TMS) in Schizophrenia
Until recently stimulation of nervous tissue deeper than approximately 2 cm from the scalp (will hence be called non-deep TMS) was not possible (3).A new coil ("H"-coil invented in Weizmann Institute of Science, Neurobiology…
- Trial name
- NCT00564096
- Testing
- DEEP TMS H1 coil, Deep H1 coil TMS
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- BeerYaakov Mental Health Center
Healthy
First-in-Human Single and Multiple Dose of GLPG1972
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1972 given to healthy subjects, compared to placebo.
- Trial name
- NCT02612246
- Testing
- GLPG1972 single ascending doses, GLPG1972 multiple ascending doses
- Where
- Belgium
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Healthy
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers
This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers
- Trial name
- NCT04159961
- Testing
- DWJ211
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Metastatic Melanoma
TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma
This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.
- Trial name
- TUNINTIL-2 (NCT06961786)
- Testing
- TILT-123, TIL, Cyclophosphamide
- Where
- Denmark
- Volunteers
- 9 people
- Sponsor
- TILT Biotherapeutics Ltd.
Malaria
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz
This study assessed the effect of multiple doses of a moderate inducer of cytochrome P450 (CYP) 3A4 (efavirenz) on the pharmacokinetics (PK) of ganaplacide and lumefantrine combination.
- Trial name
- NCT05330273
- Testing
- Ganaplacide, Lumefantrine, Efavirenz
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Diabetes, Diabetes Mellitus, Type 2
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects
This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01690169
- Testing
- NNC0113-0987
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Systemic Lupus Erythematosus, Rheumatoid Arthritis
A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases
The purpose of this study is to learn about the safety and effects of the study medication called PF-08154225 for the potential treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Idiopathic Inflammatory Myositis, Systemic Sclerosis
- Trial name
- NCT07782450
- Testing
- PF-08154225
- Volunteers
- 54 people
- Sponsor
- Pfizer
Patients With Advanced Solid Tumors
Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors
This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.
- Trial name
- NCT07661797
- Testing
- LNF2105(Antibody-Drug Conjugate (ADC) targeting Nectin-4)
- Volunteers
- 294 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Advanced Solid Tumor
A First-in-Human Study of BG-92505 Alone or in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
The purpose of this study is to test if the BG-92505 is safe and if it works in patients with advanced solid tumors when it is given on its own or in combination with anti-cancer agents.
- Trial name
- NCT07896460
- Testing
- BG-92505, Anti-Cancer Agent
- Volunteers
- 137 people
- Sponsor
- BeOne Medicines
Solid Tumors
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement
The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.
- Trial name
- NCT00882180
- Testing
- ALN-VSP02
- Where
- 10 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- Alnylam Pharmaceuticals
Influenza
A Study Evaluating the Safety and Tolerability of a Seasonal Influenza Vaccine Containing LIQ001
This study is designed to evaluate the safety, tolerability, and immune response of LIQ001 mixed with a commercially available seasonal influenza vaccine (Fluzone) in two populations of subjects; healthy adult subjects 18 to 49…
- Trial name
- LIfT (NCT01224262)
- Testing
- Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine), LIQ001 (0.45mg), LIQ001 (1.8mg)
- Where
- United States
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Liquidia Technologies, Inc.
Parkinson's Disease
Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® PD01A vaccinations in patients with Parkinson's disease.
- Trial name
- AFF008A (NCT02216188)
- Testing
- AFFITOPE® PD01A, Control
- Where
- Austria
- Volunteers
- 28 people
- Sponsor
- Affiris AG
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
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