Clinical trials: System Safety
Diabetes Mellitus, Type 2
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.
- Trial name
- NCT01478399
- Testing
- PB1023 Injection
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Acute Ischemic Stroke
DS1040b/Aspirin Drug/Drug Interaction Study
This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects. It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well…
- Trial name
- NCT02071004
- Testing
- DS-1040b, Aspirin
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Cystic Fibrosis
A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis
Evaluate the safety and tolerability of VX-659 in healthy subjects
- Trial name
- NCT03029455
- Testing
- VX-659, Tezacaftor, Ivacaftor
- Where
- 10 sites in United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Colorectal Cancer
CB-17-08 Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.
The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative…
- Trial name
- NCT03954548
- Testing
- CB-17-08 CADe
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Cosmo Artificial Intelligence-AI Ltd
HIV Infections
Pre-Exposure Prophylaxis Using TMC278LA
Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV…
- Trial name
- NCT01049932
- Testing
- TMC278LA
- Where
- 4 sites in United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- St Stephens Aids Trust
Muscle Loss, Obesity
Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt
The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists.
- Trial name
- QUALITY (NCT06282458)
- Testing
- Enobosarm, Semaglutide
- Where
- 14 sites in United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Veru Inc.
HIV Infections
Safety of and Immune Response to an HIV DNA Plasmid Vaccine Followed by HIV Adenoviral Vector Vaccine in Healthy African Adults
The purpose of this study is to evaluate the safety and tolerability of and immune response to an HIV DNA vaccine followed by an adenoviral vector HIV vaccine in healthy African adults at risk for HIV infection.
- Trial name
- NCT00415649
- Testing
- VRC-HIVDNA016-00-VP, VRC-HIVADV014-00-VP
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Alzheimer's Disease
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147
This Phase I clinical study is a randomized, double-blind, placebo-controlled, parallel-design study to thoroughly assess the safety profile and PK properties of J147 in healthy subjects.
- Trial name
- NCT03838185
- Testing
- J147
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Abrexa Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus (T2DM), Obesity
A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes…
- Trial name
- NCT06279234
- Testing
- Rosuvastatin, Midazolam, Omeprazole
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infection
Study of Single IV Administration of P2G12
A randomised phase I trial of a monoclonal antibody which neutralises HIV-1 (P2G12) to be given as a single intravenous infusion to healthy human volunteers to assess the safety and reactogenicity
- Trial name
- FuturePharma (NCT02923999)
- Testing
- P2G12 Dose Cohort 1, P2G12 Dose Cohort 2, P2G12 Dose Cohort 3
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Primary IgA Nephropathy
A Trial of HR19042 Capsule in Healthy Chinese Subjects
The study is being conducted to evaluate the safety and pharmacokinetics of HR19042 capsule after single administration in healthy Chinese subjects.
- Trial name
- NCT04887532
- Testing
- HR19042 capsule
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Diabetes, Healthy
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects
This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin…
- Trial name
- NCT01868555
- Testing
- insulin degludec, insulin degludec/insulin aspart 30, insulin degludec/insulin aspart 45
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Liver Failure
Single-Dose Pharmacokinetics and Safety of Oral Lofexidine in Hepatically-Impaired Subjects
This is a Phase 1, open-label, parallel-group, single-dose study of lofexidine in 6 adult subjects with mild hepatic impairment (Child Pugh score of 5 6), 6 adult subjects with moderate hepatic impairment (Child Pugh score 7 9)…
- Trial name
- NCT02318836
- Testing
- Lofexidine Hydrochloride (HCl) tablets
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Rheumatoid Arthritis
A Clinical Trial of Safety and Tolerance of TQH3821 Tablets in Adult Healthy Subjects
This study was a randomized, double-blind, placebo-controlled phase I clinical trial of TQH3821 in adult healthy subjects, which plans to recruit 72 healthy subjects.
- Trial name
- NCT05380934
- Testing
- TQH3821 tablets, Methotrexate tablets
- Where
- China
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941
This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.
- Trial name
- NCT01288898
- Testing
- ASP1941
- Where
- Netherlands
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
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
Depressive Disorder, Treatment-Resistant, Stress Disorders, Post-Traumatic
Ketamine Infusions for PTSD and Treatment-Resistant Depression
The relationship between depression and trauma is well established. Co-occuring depression and post-traumatic stress disorder (PTSD) are associated with more severe symptoms and lower levels of functioning.
- Trial name
- NCT02577250
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Minneapolis Veterans Affairs Medical Center
HIV Infections
Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)
This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
- Trial name
- NCT00350623
- Testing
- MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520), MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520)
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pruritus, Cholestasis
Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus
This first in human, Phase 1/1b trial will evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EP547 in healthy subjects and subjects with cholestatic or uremic pruritus.
- Conditions
- Pruritus, Cholestasis, Kidney Failure
- Trial name
- NCT04510090
- Testing
- EP547
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Escient Pharmaceuticals, Inc
Immune System
Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer
Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide, an immunomodulator and tissue repair inducer, in healthy volunteers.
- Trial name
- ECDA000/02 (NCT06312423)
- Testing
- Oligonucleotides, Phosphorothioate
- Where
- Argentina
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Ministry of Public Health of the Province of La Rioja
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