Clinical trials: Healthy Humans
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
Hemorrhagic Fever, Ebola
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
- Trial name
- NCT02661464
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 16 sites in United States, Burkina Faso and 5 more
- Volunteers
- 677 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Anti-Hepatitis A Antibody Levels in Heathy Subjects
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled.
- Trial name
- GamaSTAN (NCT03351933)
- Testing
- Immune Globulin (Human)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Grifols Therapeutics LLC
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
SARS-CoV-2, Influenza
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
- Trial name
- NCT05375838
- Testing
- mRNA-1073, mRNA-1010, mRNA-1273
- Where
- 14 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza, Pandemic
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
- Trial name
- IN-NE-rH5 (NCT05397119)
- Testing
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
Healthy
Assessing Choice in the Employer Setting (ACES) Study
The purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the employer setting when compared to a control group.
- Trial name
- MA181 (NCT00808808)
- Testing
- Choice of TIV or FluMist with baseline advertisement, Choice of TIV or FluMist with enhanced advertisement and incentives, Control - Usual care offering TIV only with baseline advertisement
- Where
- 47 sites in United States
- Volunteers
- 4,411 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Infections, Papillomavirus
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV…
- Trial name
- NCT00947115
- Testing
- Blood sampling, Cervico-vaginal secretion (CVS) samples
- Where
- 6 sites in Germany, Poland
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Leishmaniasis
Safety, Tolerability and Pharmacokinetics (PK) Investigation of GSK3494245 in Healthy Participants
This study is the first to test GSK3494245 in humans, to evaluate its safety, tolerability, and pharmacokinetics (PK) after a single dose.
- Trial name
- NCT04504435
- Testing
- GSK3494245
- Where
- United Kingdom
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Viral Infections, Respiratory Syncytial Virus Infections
Safety and Tolerability Study to Evaluate MEDI-534 in Children 6 to < 24 Months of Age
The overall objective of the MEDI-534 clinical development program is to evaluate the safety, efficacy and tolerability of MEDI-534 for the prevention of serious RSV and PIV3 disease in young infants.
- Conditions
- Respiratory Viral Infections, Respiratory Syncytial Virus Infections, Parainfluenza Virus 3, Human
- Trial name
- CP149 (NCT00493285)
- Testing
- MEDI-534
- Where
- 30 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Human Influenza
Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, Including MF59C.1 Adjuvant, in Healthy Adults ≥65 Years of Age
The present study is designed to confirm the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant, formulation 2013/2014 Northern Hemisphere, in adults ≥65 years of…
- Trial name
- NCT01879540
- Testing
- aTIV
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements.
- Trial name
- NCT02478463
- Testing
- Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis C
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.
- Trial name
- NCT02159352
- Testing
- Daclatasvir, Darunavir, Ritonavir
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Influenza
A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and…
- Trial name
- NCT02918006
- Testing
- VXA-A1.1, Fluzone®
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Vaxart
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Influenza
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the…
- Trial name
- NCT00836953
- Testing
- Influenza virus vaccine (Pediatric formulation)
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza, Human
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza…
- Trial name
- NCT05540522
- Testing
- Quadrivalent influenza modRNA vaccine, Quadrivalent influenza vaccine
- Where
- 321 sites in United States, Argentina and 4 more
- Volunteers
- 45,789 people, healthy volunteers welcome
- Sponsor
- Pfizer
Arthritis, Rheumatoid
First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response.
- Trial name
- NCT03426995
- Testing
- GSK3358699, GM-CSF, LPS
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline