Clinical trials: System Safety
HIV Infections
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers
Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the rabies glycoprotein (ALVAC rabies glycoprotein) as…
- Trial name
- NCT00000813
- Testing
- ALVAC-HIV gp160MN (vCP125), ALVAC-RG Rabies Glycoprotein (vCP65), rgp120/HIV-1 SF-2
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Encephalitis, Tick-borne
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers…
- Trial name
- NCT00161876
- Testing
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Where
- 8 sites in Poland
- Volunteers
- 3,973 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alzheimer Disease
Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics From Single Dose of Intramuscular (IM) and Subcutaneous (SC) Donepezil (GB-5001) Injections Versus Donepezil Oral Tablet (Aricept®) in Healthy Male Volunteers
This study is to evaluate the safety and tolerability of single dose of GB-5001 (donepezil) IM and SC depot in healthy male Adults.
- Trial name
- NCT06127368
- Testing
- GB-5001A, GB-5001D, Oral cohort
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- G2GBio, Inc.
Covid19, Myopathy
Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study
This study is a prospective observational study. We aim to investigate the safety and efficacy of inactivated SARS-CoV-2 vaccine between immune-related myopathy (myasthenia gravis and inflammatory myopathy) patients and health…
- Trial name
- NCT04941079
- Testing
- no intervention
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Chongqing Medical University
Urea Cycle Disorders, Inborn, Urea Cycle Disorders
Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD
Phase 1/2 Study of KRRO-121 is a randomized, placebo-controlled study in Healthy Volunteers (Phase 1 SAD and MAD) and Study Participants with Urea Cycle Disorders (Phase 2).
- Conditions
- Urea Cycle Disorders, Inborn, Urea Cycle Disorders, Ornithine Transcarbamylase (OTC) Deficiency, Arginase 1 Deficiency
- Trial name
- ANCHOR (NCT07773246)
- Testing
- KRRO-121
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Korro Bio, Inc.
Hepatitis B
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
Primary objective: To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a…
- Trial name
- NCT00693186
- Testing
- HBVaxPRO® 5 µg / 0.5 mL, Engerix B® 10 µg / 0.5 mL
- Where
- 5 sites in Italy
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Asthma
GSK2190915 Safety and Pharmacokinetic Study in Healthy Japanese Subjects
GSK2190915 is currently in development for the treatment of asthma. This study aims to assess the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects.
- Trial name
- NCT00955383
- Testing
- GSK2190915
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Muscle Atrophy
Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.
An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis
- Trial name
- STEM-MYO (NCT05211986)
- Testing
- IMM01-STEM
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Immunis, Inc.
Celiac Disease, Healthy
A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug.
- Trial name
- NCT07063823
- Testing
- HB-2121
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Nielsen Fernandez-Becker
HIV Infections
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
This first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy adults.
- Trial name
- NCT04672083
- Testing
- CPT31
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Navigen, Inc.
Systemic Lupus Erythematosus
A Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Self-Administered Subcutaneously (SC) by Healthy Subjects
This will be a randomized, parallel-group, open-label, single-dose study of belimumab in healthy subjects to estimate the relative bioavailability, tolerability and safety of a single dose of belimumab 200 milligram (mg) when…
- Trial name
- NCT01894360
- Testing
- Belimumab 200 mg/mL
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis, Spondyloarthritis
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases
The prognosis of rheumatic diseases has improved considerably with development of therapy. However, infections are considered the most important cause of morbidity and mortality in this group of patients.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Systemic Lupus Erythematosus (SLE), Dermatomyositis (DM)
- Trial name
- NCT01151644
- Testing
- Anti-pandemic H1N1 influenza vaccine
- Where
- Brazil
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Atopic Dermatitis
A Study of TQH2722 Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Efficacy and Immunogenicity in Healthy Adult Subjects
A randomized, double-blind, placebo-controlled trial design was used to assess the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, and immunogenicity of TQH2722 injection in healthy subjects.
- Trial name
- NCT05409326
- Testing
- TQH2722 injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Venezuelan Equine Encephalomyelitis
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
- Trial name
- VEE TC-83 (NCT00582504)
- Testing
- VEE TC-83
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Non Alcoholic Steatohepatitis
the Efficacy and Safety of Diosmin on Non-diabetic Patients With Non-alcoholic Steatohepatitis.
This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin on non-diabetic patients with non-alcoholic…
- Trial name
- NCT05942547
- Testing
- Diosmin
- Where
- Egypt
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Tanta University
Hepatitis C
Drug Interaction Study Between Eltrombopag and Lopinavir/Ritonavir in Healthy Adult Subjects.
This is a Phase I, open-label, single sequence, crossover study to be conducted in healthy adult subjects. There will be a screening visit, three treatment periods, and a follow-up visit.
- Trial name
- NCT00833378
- Testing
- Eltrombopag, Lopinavir/Ritonavir, Eltrombopag and Lopinavir/Ritonavir
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Colon Cancer, Colon Polyp
Feasibility and Safety of Single Port Robot in Colorectal Procedures
The purpose of this study is to evaluate the safety and feasibility of using the Single Port (SP) robot (daVinci, Intuitive Surgical) to perform single port robotic colon surgery and transanal robotic surgery.
- Conditions
- Colon Cancer, Colon Polyp, Rectal Cancer, Diverticulitis
- Trial name
- NCT03700593
- Testing
- Single Port Robotic Colorectal Surgery
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Marks Colorectal Surgical Associates
HIV Infections
Evaluating the Safety of and Immune Response to the VSV-Indiana HIV Vaccine in Healthy, HIV-Uninfected Adults
The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in HIV-uninfected adults. Study researchers will also determine the maximum dose of the vaccine that participants can safely receive.
- Trial name
- NCT01438606
- Testing
- VSV-Indiana HIV gag vaccine
- Where
- 4 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis B
Immunogenicity and Safety of a Novel Adjuvanted HBV Vaccine in Healthy Volunteers Positive for the HLA-DQ2 Genotype
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
- Trial name
- NCT00697749
- Testing
- HBV-MPL vaccine 208129, Engerix™-B
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Atopic Dermatitis, Rheumatoid Arthritis
MH004 Topical Cream in Healthy Adult Volunteers and Participants With Atopic Dermatitis or Rheumatoid Arthritis
This is a Phase Ia/Ib Study of MH004 in Healthy Adult Volunteers, participants with Mild to Moderate Atopic Dermatitis and participants with Mild to Moderate Rheumatoid Arthritis.
- Trial name
- NCT04815148
- Testing
- MH004 Ia(0.1%), MH004 Ia(0.3%), MH004 Ia(1%)
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Minghui Pharmaceutical Pty Ltd
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