Clinical trials: Safety Study
Healthy
A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.
- Trial name
- NCT02376400
- Testing
- MVA-BN-Filo, Ad26.ZEBOV
- Where
- 2 sites in Tanzania, Uganda
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
HIV
Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring
This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive…
- Trial name
- TDF IVR-001 (NCT02006264)
- Testing
- TDF Intravaginal Ring
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Albert Einstein College of Medicine
Short Bowel Syndrome
Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children.
- Trial name
- NCT00767364
- Testing
- Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Michigan
Hypertension, Hyperlipidemia
Drug Interaction and Safety Between Valsartan and Rosuvastatin in Healthy Male Volunteers
Primary objective : To investigate pharmacokinetics after concomitant administration of valsartan and rosuvastatin compared to single administration of valsartan or rosuvastatin in healthy male volunteers Secondary objective : To…
- Trial name
- NCT01918709
- Testing
- Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R), Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R), Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Plaque, Gingivitis
Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
- Trial name
- APCG (NCT01877421)
- Testing
- 2 mg KSL-W, 4 mg KSL-W, 6 mg KSL-W
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects
This is a double-blind, placebo-controlled, randomized, parallel group, two-part study where single IV doses of GSK2831781 will be administered to healthy Japanese and Caucasian subjects in part A and SC doses will be…
- Trial name
- NCT03965533
- Testing
- GSK2831781
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Sleep Disturbance, Sleep Quality
A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of Various Cannabinoids on Sleep Quality
This double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to…
- Trial name
- NCT07769164
- Testing
- 2 mg THC + 2 mg CBN + 2 mg CBG + 10 mg CBD + 1 mg Melatonin, 10 mg THC + 5 mg CBN + 5 mg CBG + 20 mg CBD, 10 mg THC + 20 mg CBN + 5 mg CBG
- Where
- United States
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- Cannabis Science Innovations, LLC
Healthy, Obesity
A Study of LY3549492 in Healthy Participants and Participants With Overweight or Obesity
The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy people who are overweight or have obesity.
- Conditions
- Healthy, Obesity, Overweight
- Trial name
- NCT07232732
- Testing
- LY3549492
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic…
- Trial name
- NCT05935033
- Testing
- Emraclidine
- Where
- 3 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- AbbVie
Respiratory Syncytial Viruses, Respiratory Tract Diseases
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory…
- Trial name
- CYPRESS (NCT03982199)
- Testing
- RSV Vaccine
- Where
- 40 sites in United States
- Volunteers
- 5,815 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Poliomyelitis, Polio
Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV
This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a…
- Trial name
- NCT00348387
- Testing
- Poliomyelitis Vaccine inactivated, Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
- Where
- 2 sites in China
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Fever, Dengue Hemorrhagic Fever
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Primary Objectives: To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
- Conditions
- Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Diseases
- Trial name
- NCT00880893
- Testing
- CYD Dengue vaccine, NaCl + influenza virus or hepatitis A vaccine
- Where
- 5 sites in Singapore
- Volunteers
- 1,198 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
NASH - Nonalcoholic Steatohepatitis
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
The study was planned in 2 parts: Parts A and B. In Part A, we tested 2 single doses of the study medicine in healthy volunteers: 500 mg and 750 mg.
- Trial name
- NCT05441904
- Testing
- PXL770
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Poxel SA
Chronic HBV Infection
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects.
- Trial name
- NCT04008004
- Testing
- EDP-514
- Where
- 15 sites in United States, Canada
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Proliferative Diabetic Retinopathy (PDR)
Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X
The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc.
- Trial name
- NCT01869933
- Testing
- OC-10X
- Where
- Bangladesh
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- OcuCure Therapeutics, Inc.
Healthy
A Study of LY3981314 in Healthy Participants
The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), and how it's processed in the body.
- Trial name
- NCT07005284
- Testing
- LY3981314
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Dry Eye, Eye Fatigue
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of an Oral Supplement in Supporting Vision and Eye Health
This is a 4-week virtual randomized, triple-blinded, placebo-controlled clinical trial evaluating the safety and efficacy of Eye Empower, an oral supplement, in adults aged 45 or older experiencing dry eyes, irritation, and…
- Trial name
- NCT07123584
- Testing
- Eye Empower
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bio Nature Health
Wounds and Injuries
Safety and Efficacy of AR/101 in Accelerating Re-epithelialization of Split Thickness Wounds
This clinical study will be a prospective, placebo-controlled, double-blind, randomized and centrally evaluated intra-individual comparative study to assess the safety and efficacy of AR/101 concomitantly administered with…
- Trial name
- NCT02602184
- Testing
- AR/101
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Arava Bio Tech Ltd.
Healthy
Safety and Efficacy of EZ-Ject Injector a Pain-Free Subcutaneous Automatic Injection in Healthy Volunteers
Subcutaneous injections are a widely used method for drug delivery. One of its major drawbacks is the pain inflicted during the process.
- Trial name
- NCT00684333
- Testing
- painless subcutaneous injection by EZ-Ject Injector
- Where
- Israel
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Sindolor
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