Clinical trials: Evaluate the Safety and Tolerability
Phenylketonuria
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)
This study is an international, multi-center, randomized, double-blind, placebo-controlled, two-treatment, two-period cross-over study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of a single oral…
- Trial name
- NCT04085666
- Testing
- CDX 6114
- Where
- 2 sites in Australia, Germany
- Volunteers
- 18 people
- Sponsor
- Société des Produits Nestlé (SPN)
BACTERIAL VAGINOSIS
Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis
THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
- Trial name
- VARIANT (NCT02376972)
- Testing
- RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG, METROGEL VAGINAL
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Alfasigma S.p.A.
Retinitis Pigmentosa (RP)
Prospective, Randomized, Sham-controlled, Dose-finding I/II Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)
This is a Phase 1/2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).
- Trial name
- PRISM (NCT07282457)
- Testing
- ZM-02 (low dose), ZM-02 (high dose), ZM-02 (selected dose)
- Volunteers
- 21 people
- Sponsor
- Zhongmou Therapeutics
Cryptosporidiosis
A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis
This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of treating Cryptosporidiosis in HIV positive patients with Clofazimine.
- Trial name
- NCT03341767
- Testing
- Clofazimine
- Where
- Malawi
- Volunteers
- 33 people
- Sponsor
- University of Washington
Pharmacokinetics
Combination of Fimasartan/Amlodipine/Hydrochlorothiazide in Healthy Male Subjects
The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.
- Trial name
- NCT03629067
- Testing
- Treatment T, Treatment R
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- Trial name
- NCT04865536
- Testing
- TBI-223 1800 mg, TBI-223 2400mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Staphylococcus Aureus Bloodstream Infection
A Phase I Study of XJ101 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria.
- Trial name
- NCT06014736
- Testing
- XJ101 for Injection
- Where
- China
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Starmab biologics（Shanghai）Co,.ltd
Drug Resistant Epilepsy, Epilepsy, Drug Resistant
Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy
This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.
- Conditions
- Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory
- Trial name
- NCT03860298
- Testing
- NaviFUS System
- Where
- Taiwan
- Volunteers
- 6 people
- Sponsor
- NaviFUS Corporation
Acinetobacter Baumannii Infection
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently…
- Trial name
- NCT03310463
- Testing
- ETX2514SUL
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Entasis Therapeutics
Lupus Erythematosus, Systemic
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
- Trial name
- NCT00071487
- Testing
- Belimumab 1 mg/kg, Belimumab 4 mg/kg, Belimumab 10 mg/kg
- Where
- 62 sites in United States, Canada
- Volunteers
- 449 people
- Sponsor
- Human Genome Sciences Inc.
Bacterial Infections
A Single Dose Study of Debio 1450 in Healthy Subjects
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study.
- Trial name
- NCT02162199
- Testing
- Debio 1450
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy Subjects
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TLC-2716 after single- and multiple-ascending doses in healthy subjects.
- Trial name
- NCT05483998
- Testing
- TLC-2716
- Where
- New Zealand
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- OrsoBio, Inc
Heart Failure
A Clinical Study of HRS-7156 in Healthy Participants
The purpose of this Phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-7156 in healthy participants.
- Trial name
- NCT07601087
- Testing
- HRS-7156
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Irritable Bowel Syndrome
Efficacy, Safety, and Tolerability of Eluxadoline in the Treatment of Participants With Diarrhea-Predominant Irritable Bowel Syndrome (IBS-d)
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel…
- Trial name
- NCT01553747
- Testing
- Eluxadoline
- Where
- 253 sites in United States, Canada and 2 more
- Volunteers
- 1,146 people
- Sponsor
- Furiex Pharmaceuticals, Inc
Respiratory Syncytial Virus Infections
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
MEDI-524 given for up to 5 doses at 3 and 15 mg/kg to high-risk children appeared to be safe and well tolerated.
- Trial name
- NCT00192478
- Testing
- Medi-524
- Where
- 3 sites in Argentina, Chile
- Volunteers
- 217 people
- Sponsor
- MedImmune LLC
Tuberculosis
Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis
The study is to enroll 60 participants aged 18-65 years old, including 30 healthy subjects and 30 tuberculosis patients. Low-dose (2.5 μg/ml), medium-dose (5 μg/ml), and high-dose (10 μg/ml) studies will be conducted separately…
- Trial name
- NCT06224608
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)
- Where
- 2 sites in China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Chengdu CoenBiotech Co., Ltd
Warm Antibody Autoimmune Hemolytic Anemia
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
- Trial name
- wAIHA (NCT05535933)
- Testing
- HMPL-523(300mg PO QD)
- Where
- 39 sites in China
- Volunteers
- 111 people
- Sponsor
- Hutchmed
Primary Immune Deficiency Disorder
Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases
Clinical phase 3 study to evaluate the efficacy, tolerability and safety of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases.
- Trial name
- NCT03988426
- Testing
- Octanorm
- Where
- 5 sites in Russia
- Volunteers
- 25 people
- Sponsor
- Octapharma
Diabetes Mellitus
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
- Trial name
- NCT02302443
- Testing
- HM12470, Active comparator
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced Solid Tumors
Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection
Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.
- Trial name
- NCT05620017
- Testing
- BAT8008 for Injection
- Where
- 2 sites in China
- Volunteers
- 182 people
- Sponsor
- Bio-Thera Solutions