Clinical trials: System Safety
Healthy Volunteer, Muscular Atrophy, Spinal
A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene Abeparvovec
In this study, researchers will learn about a study drug called BIIB115 in healthy adult male volunteers and in participants with spinal muscular atrophy (SMA). This study will focus on children with SMA.
- Trial name
- NCT05575011
- Testing
- BIIB115
- Where
- 16 sites in Belgium, Canada and 7 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Biogen
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
Hiv, HSV
Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG
The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG).
- Trial name
- NCT03762772
- Testing
- TAF/EVG Vaginal Insert
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- CONRAD
Rheumatoid Arthritis, Non-Alcoholic Steatohepatitis
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.
- Trial name
- NCT05053165
- Testing
- LB-P6, LB-P8
- Where
- Australia
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- LISCure Biosciences
Hearing Loss, Cancer
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.
- Trial name
- NCT01452607
- Testing
- SPI-1005
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sound Pharmaceuticals, Incorporated
Asthma
The Study of Single Dose Administration of GR2002 Injection in Chinese Health Volunteers
To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
- Trial name
- NCT05954611
- Testing
- GR2002 injection
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
C3 Glomerulopathy, IgA Nephropathy
Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease
The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy [C3G]…
- Trial name
- NCT05083364
- Testing
- ARO-C3
- Where
- 16 sites in Australia, Georgia and 5 more
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Allergy;Food, Food Allergy Peanut
TRANS-FOODS: Preventing Peanut Allergy Through Improved Understanding of the Transcutaneous Sensitisation Route, Novel Food Processing and Skin Care Adaptations
This project aims to study the immune responses to peanut allergen in those with a skin barrier defect with and without skin massage, specifically it aims to: 1.
- Conditions
- Allergy;Food, Food Allergy Peanut, Pathways and Sources of Exposure
- Trial name
- TRANS-FOODS (NCT05407012)
- Testing
- Application of the barrier enhancing preparation.
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- King's College London
Hepatitis C, Chronic
First in Human Study of ALS-002200; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC)…
- Trial name
- NCT01590407
- Testing
- ALS-002200
- Where
- 4 sites in France, Moldova and 1 more
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Type 1 Diabetes Mellitus
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients
Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.
- Trial name
- NCT02625636
- Testing
- SAR438544, r-glucagon
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Sanofi
Type 2 Diabetes Mellitus (T2DM), Food Effect
Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes
The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Food Effect, Safety and Tolerability, Obesity
- Trial name
- NCT07098663
- Testing
- MKP10241
- Where
- Australia
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Mankind Pharma Limited
Alzheimer Disease, Healthy Volunteers
Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants
The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants…
- Trial name
- NCT02769065
- Testing
- TAK-071, Donepezil
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Takeda
Allergic Rhinitis
A Safety and Immunogenicity Phase IC Study of CryJ2 -DNA-LAMP Plasmid Vaccine for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device
This is a research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is tolerated and how research participants respond…
- Trial name
- NCT02146781
- Testing
- CryJ2-DNA-LAMP plasmid vaccine by intradermal injection, Saline Control
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Immunomic Therapeutics, Inc.
Healthy Volunteers, Alzheimer Disease
A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
This study involves single and multiple doses of LY3202626 and will evaluate the effects of LY3202626 on the body. There will be 4 parts to this study.
- Trial name
- NCT02323334
- Testing
- LY3202626, Itraconazole
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
Tobacco Use Cessation
Ask Advise Connect (AAC) Harris Heath CPRIT
The goal of this behavioral research study is to learn about the outcomes of smoking cessation treatment. Researchers want to learn how many smokers stopped smoking after taking part in smoking cessation treatment with the Texas…
- Trial name
- NCT01788787
- Testing
- Quitline-Delivered Proactive Telephone Counseling, Follow-Up Phone Call, Smoking Cessation Training
- Where
- United States
- Volunteers
- 5,212 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Atopic Dermatitis
LEO 29102 Single and Multiple Dose Study by Dermal Application
The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects.
- Trial name
- NCT00891709
- Testing
- LEO 29102
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
Parkinson's Disease, Parkinsonism
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients
This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's…
- Trial name
- NCT04075318
- Testing
- UB-312
- Where
- Netherlands
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- United Neuroscience Ltd.
Chronic Spontaneous Urticaria (CSU), Healthy Volunteers
Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).
This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with…
- Trial name
- NCT07684560
- Testing
- Alpha-0261
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
Japanese Encephalitis
Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea
To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12~23 months
- Trial name
- NCT01150942
- Testing
- JE vaccine
- Where
- South Korea
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Boryung Pharmaceutical Co., Ltd
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