Clinical trials: Dose Finding Study
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
- Trial name
- NCT00973349
- Testing
- MF59-eH1N1_f
- Where
- 21 sites in United States, Mexico
- Volunteers
- 2,719 people, healthy volunteers welcome
- Sponsor
- Novartis
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infection
Study of an Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers
The primary objectives of the study were: To assess the safety profile of each dose of the study product after each and any administration in all infants and toddlers regardless of baseline serostatus.
- Trial name
- VAD00001 (NCT04491877)
- Testing
- RSV vaccine formulation 1, RSV vaccine formulation 2
- Where
- 29 sites in United States, Chile and 1 more
- Volunteers
- 259 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Respiratory Tract Infection
A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may…
- Trial name
- NCT03572062
- Testing
- Formulation A, Formulation B, Formulation C
- Where
- 16 sites in United States, Australia
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Healthy
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates.
- Trial name
- NCT02816346
- Testing
- Shigella sonnei 53G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PATH
Cytomegalovirus Infection
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
- Trial name
- NCT04232280
- Testing
- mRNA-1647
- Where
- 9 sites in United States
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
- Trial name
- COVID-19 DTH (NCT05216510)
- Testing
- TNX-2110, TNX-2120, TNX-2130
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Healthy
A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single…
- Trial name
- NCT04771286
- Testing
- BI 1015550 (C-14)
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Respiratory Tract Infections
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).
- Trial name
- NCT03529773
- Testing
- Formulation A, Formulation B
- Where
- 40 sites in United States
- Volunteers
- 1,235 people, healthy volunteers welcome
- Sponsor
- Pfizer
Arthroscopic Knee Surgery
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around…
- Trial name
- NCT01701102
- Testing
- Mepivacaine (24 mg) plus fentanyl, Mepivacaine (27 mg) plus fentanyl, Mepivacaine (30 mg) plus fentanyl
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
Insufficient Physical Activity
A BCT Intervention for Physical Activity Among Individuals on Statins
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin…
- Trial name
- NCT05273723
- Testing
- 5 Behavioral Change Techniques
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Northwell Health
Covid19, SARS-CoV Infection
SARS-CoV-2 Human Challenge Characterisation Study
This is a dose optimisation study in healthy adults aged 18-30 who will be experimentally inoculated with SARS-CoV-2. The aim is to cause PCR-confirmed upper respiratory infection in the majority of challenged individuals with…
- Conditions
- Covid19, SARS-CoV Infection, Corona Virus Infection, Coronavirus
- Trial name
- NCT04865237
- Testing
- SARS-CoV-2 Virus 1x10^1 TCID50, Remdesivir, SARS-CoV-2 Virus 1x10^2 TCID50
- Where
- 2 sites in United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Schistosomiasis, Schistosomiasis Mansoni
Praziquantel in Children Under Age 4
The overall goals of this proposal are to conduct a trial to address the significant gaps with respect to our understanding of best approaches to treatment of children ages 1-4 with intestinal schistosomiasis.
- Conditions
- Schistosomiasis, Schistosomiasis Mansoni, Schistosoma Japonicum Infection
- Trial name
- PIP (NCT03640377)
- Testing
- Praziquantel
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.
- Trial name
- NCT02334982
- Testing
- TAK-137
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Takeda
Ebolavirus Disease
VSV-ZEBOV Geneva Vaccine Trial
The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time.
- Trial name
- VSV-ZEBOV (NCT02287480)
- Testing
- VSV-ZEBOV
- Where
- Switzerland
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Healthy
A Study in Healthy Men to Find the Best Formulation of BI 894416 and to Test How This is Taken up in the Body
The main objective of this trial is to select a formulation principle (tablet vs. capsule) and to optimize the identified extended release formulation of BI 894416, if needed.
- Trial name
- NCT04232839
- Testing
- BI 894416 Reference Formulation, BI 894416 Formulation A2, BI 894416 Formulation C2
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers
This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16.
- Trial name
- UWI-02 (NCT01769573)
- Testing
- RG-HRV16
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison