Clinical trials: System Safety
HIV Infections
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)
To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers.
- Trial name
- NCT00000968
- Testing
- gp160 Vaccine (Immuno-AG)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C Virus
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
- Trial name
- NCT00810758
- Testing
- PF-04878691 3mg, PF-04878691 6mg, PF-04878691 9mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Parkinson Disease
Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics
To investigate the effect of four single oral doses of BIA 6-512 (25 mg, 50 mg, 100 mg and 200 mg) on levodopa pharmacokinetics when administered in combination with a single-dose of controlled release levodopa/benserazide 100/25…
- Trial name
- NCT03091543
- Testing
- Madopar® HBS 125, BIA 6-512 25 mg dose, BIA 6-512 50 mg dose
- Where
- Portugal
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Heart Attack, Stroke
CV Wizard: Does a Clinical Decision Support Tool Improve CVD Risk Factor Control in Safety Net Clinics?
This project aims to reduce disparities in cardiovascular disease (CVD) risk factor control and in rates of heart attacks and strokes among the low-income, racially / ethnically diverse Americans who receive primary care at…
- Conditions
- Heart Attack, Stroke, Cardiovascular Diseases
- Trial name
- CV_WIZARD (NCT03001713)
- Testing
- CV WIZARD
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
Botulism
Phase I, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NTM-1632
This is a Phase I, randomized, double-blind, placebo controlled dose escalation trial to evaluate NTM-1632 in three dose cohorts (A: 0.033 mg/kg, B: 0.165 mg/kg, and C: 0.33 mg/kg).
- Trial name
- NCT02779140
- Testing
- NTM-1632
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pain, Migraine Disorders
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study Of PF-04427429 In Healthy Women Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04427429 in healthy women.
- Trial name
- NCT01511497
- Testing
- PF-04427429, Normal saline
- Where
- 3 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy, Hepatitis C
A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials
- Trial name
- NCT01732848
- Testing
- BMS-986094/INX-08189
- Where
- 5 sites in United States, Puerto Rico
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
NAFLD, Nonalcoholic Fatty Liver Disease
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.
- Conditions
- NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03674476
- Testing
- BMS-986036
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
Role of Roflumilast in Ulcerative Colitis
This study aims to investigate possible efficacy and safety of Roflumilast in adult patients with ulcerative colitis disease .
- Trial name
- NCT05684484
- Testing
- Roflumilast 500 MCG Oral Tablet [DALIRESP], amino salicylic acid
- Where
- Egypt
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Tanta University
Myopia, Hyperopia
Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia
This purpose of this study is to evaluate the safety and effectiveness of a topography-based custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating myopia and hyperopia.
- Trial name
- NCT01028378
- Testing
- T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
- Where
- 10 sites in United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Clinical Research Consultants, Inc.
HIV Infections
Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Chimp Adenovirus Vaccines Expressing Clade C gp140 & CH505TF gp120 Protein Boost in HIV-uninfected Adult.
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult…
- Trial name
- HVTN139 (NCT05182125)
- Testing
- AdC6-HIVgp140, AdC7-HIVgp140, CH505TF gp120
- Where
- 6 sites in South Africa
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network
Alzheimer Disease
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD)…
- Trial name
- NCT00479349
- Testing
- SAM-531
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Polycystic Ovary Syndrome (PCOS), Female Endocrine Disorder
A Study of AZD4901 in Females With Polycystic Ovary Syndrome
To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
- Trial name
- NCT01872078
- Testing
- AZD4901 (oral)
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Immunoglobulin A Nephropathy
A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.
This is a Phase I/II study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.
- Trial name
- NCT07375758
- Testing
- MIL116
- Where
- China
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
HIV Infections
A Study to Investigate Safety, Tolerability and Pharmacokinetics of VH5356136 in Adult Participants Without HIV
The study aims to evaluate the safety, tolerability and pharmacokinetic (PK) properties of a single dose of VH5356136 in adult participants without human immunodeficiency virus (HIV).
- Trial name
- NCT07822477
- Testing
- VH5356136 Formulation 1, VH5356136 Formulation 2
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Diabetes Mellitus, Type 2
Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)
This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy participants.
- Trial name
- NCT01223339
- Testing
- Ertugliflozin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Multiple Sclerosis, Pregnancy
Kesimpta (Ofatumumab) Pregnancy Registry
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
- Trial name
- NCT05634967
- Testing
- Kesimpta
- Where
- United States
- Volunteers
- 725 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cerebral Palsy
HMB Cerebral Palsy Pilot Study
This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy. The primary objective is to quantify safety, compliance, and acceptability of daily combined HMB + Vitamin…
- Trial name
- NCT05384951
- Testing
- HMB + Vitamin D3
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Gillette Children's Specialty Healthcare
Healthy Volunteers, HIV Infection
Safety Study Comparing a Vaccine Transcutaneous Administration to the Intramuscular Route
The rationale for transcutaneous vaccination is based on the unique ability of cutaneous immune cells, especially Langerhans cells (LCs), to present antigens to the immune system.
- Trial name
- MANON-05 (NCT00261001)
- Testing
- Transcutaneous mode of administration, Intramuscular mode of administration
- Where
- 2 sites in Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Objectif Recherche Vaccins SIDA
Traumatic Brain Injury (TBI)
A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers
- Trial name
- NCT05033444
- Testing
- PRV-002
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Odyssey Group International, Inc.
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