Clinical trials: System Safety
Acute Allergic Reaction, Anaphylaxis
Phase 1 Crossover Study Evaluating the Safety, Tolerability, and Pharmacokinetics of KP001 in Healthy Adult Volunteers
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of several KP001 dose regimens to identify a treatment regimen with a PK profile that safely meets or exceeds the PK profile of…
- Trial name
- NCT06963411
- Testing
- KP001
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Kokua Pharma Inc.
HIV Infections
Evaluating the Safety of Tenofovir Vaginal Gel in HIV-Uninfected Pregnant Women
Preliminary research has shown that a vaginal gel containing the antiretroviral (ARV) drug tenofovir may reduce the risk of HIV infection in women when used near the time of sexual intercourse.
- Trial name
- NCT01490671
- Testing
- 1% tenofovir gel
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis
A Single-ascending Dose (Part A) and Repeat-dose (Part B) Study to Investigate the Safety, Pharmacokinetics and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B)
The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants…
- Trial name
- NCT05277571
- Testing
- UCB1381
- Where
- 16 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Cystic Fibrosis
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9)
The present study is designed to assess the safety and tolerability of escalating, multiple ascending doses of Cavosonstat (N91115) in healthy subjects.
- Trial name
- (SNO-9) (NCT02934139)
- Testing
- Cavosonstat
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Nivalis Therapeutics, Inc.
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Seneorineural Deafness, Sudden Sensorineural Hearing Loss
A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients
The goal of this 2 step-up, exploratory study is to test safey, tolerability and PK/PD profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage…
- Trial name
- NCT06249919
- Testing
- NS101
- Where
- 15 sites in South Korea
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Neuracle Science Co., LTD.
Parkinson Disease
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers
Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.
- Trial name
- NCT02111330
- Testing
- PBF-509
- Where
- 2 sites in Spain
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Renal Insufficiency, Chronic, Hepatic Insufficiency
Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
An open-label, single-dose study to evaluate the safety and pharmacokinetics of DIC075V in subjects with mild or moderate chronic renal insufficiency and in patients with mild chronic hepatic impairment compared.
- Conditions
- Renal Insufficiency, Chronic, Hepatic Insufficiency, Healthy
- Trial name
- NCT00805090
- Testing
- Sporanox, Diclofenac Sodium
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Javelin Pharmaceuticals
Atopic Dermatitis
A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free…
- Trial name
- NCT00721331
- Testing
- nortriptyline HCl + loratadine, nortriptyline HCl, mometasone furoate
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zalicus
HIV Infection
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design.
- Trial name
- NCT02875119
- Testing
- Griffithsin Gel
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Population Council
HIV Infections
Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the…
- Trial name
- NCT00062530
- Testing
- SCBaL/M9
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 2 Diabetes
Assess Pharmacokinetics, Safety and Tolerability in Healthy Chinese Volunteers After Oral Doses of Saxagliptin
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This Phase I study is designed to assess the pharmacokinetics of saxagliptin and its pharmacologically active metabolite…
- Trial name
- NCT00770302
- Testing
- Saxagliptin
- Where
- China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Diarrhea
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E.
- Trial name
- NCT01067781
- Testing
- Heat-Labile Enterotoxin of E. coli (LT)
- Where
- 5 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Intercell USA, Inc.
Hypertension, Diabetes
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.
- Trial name
- NCT03609294
- Testing
- Treatment A (Fimasartan, Linagliptin), Treatment B (Fimasartan/Linagliptin)
- Where
- South Korea
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Hepatitis B
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine.
- Trial name
- NCT00366366
- Testing
- Infanrix-Hexa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Polio
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
- Conditions
- Diphtheria, Polio, Pertussis, Hepatitis B
- Trial name
- NCT00619502
- Testing
- DTaP-IPV-HB-PRP~T vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 254 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pertussis, Meningitis
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
The trial includes groups receiving various combinations of meningitis C and pertussis containing vaccines, to be administered concomitantly in adolescents due their school leaving booster vaccinations (as per UK routine…
- Conditions
- Pertussis, Meningitis, Preventive Immunization; Meningitis, Immunization
- Trial name
- Mutliboost (NCT02526394)
- Testing
- Meningococcal vaccine, Pertussis containing vaccine
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Public Health England
HIV Infections
A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it…
- Trial name
- NCT04826094
- Testing
- Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®
- Where
- Kenya
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smoking Cessation, Oxidative Stress
ESTxENDS Trial- Substudy on Oxidative Stress Induced by Electronic Nicotine Delivery Systems (ENDS) Measured in EBC
--> This is a substudy of the main ESTxENDS trial (NCT03589989). Oxidative stress outcomes should be considered secondary outcomes of the main smoking cessation outcome formulated in NCT03589989.
- Trial name
- ESTxENDS (NCT03612453)
- Testing
- ENDS (vaporizer/e-cig) and smoking cessation counseling, Smoking cessation counseling
- Where
- Switzerland
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- University of Bern
Encephalitis
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic
- Trial name
- NCT01047839
- Testing
- IC51
- Where
- 10 sites in United States, Australia and 3 more
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
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