Clinical trials: Controlled Human Infection
Hepatitis C
Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects: Part A: Safety and Efficacy of INX-08189 With Peg IFN Alfa-2a and Ribavirin. Part B: INX-08189 in Interferon Free Treatment With Daclatasvir and/or Ribavirin
Part A: The purpose of this study is to evaluate the safety and tolerability of INX-08189 and placebo with Peginterferon alfa-2a and Ribavirin during 12 weeks of treatment Part B: The purpose of this study is to evaluate the…
- Trial name
- NCT01425970
- Testing
- INX-08189, Pegylated interferon alfa-2a, Ribavirin
- Where
- 6 sites in United States
- Volunteers
- 210 people
- Sponsor
- Bristol-Myers Squibb
Influenza
Efficacy, Immunogenicity and Safety of OVX836 Influenza Vaccine 480μg
The present study will evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years.
- Trial name
- NCT05569239
- Testing
- OVX836 480µg, Saline Solution
- Where
- 16 sites in Belgium, Finland and 2 more
- Volunteers
- 2,891 people, healthy volunteers welcome
- Sponsor
- Osivax
HIV Infection
Pharmacokinetics of Apricitabine and Tipranavir When Dosed Alone or Together
The aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.
- Trial name
- NCT00352066
- Testing
- apricitabine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Avexa
Influenza
Safety and Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived)
The objective of this study is to assess the safety, tolerability and immunogenicity of a Split Virus, Vero Cell derived, Seasonal Influenza Vaccine (VCIV) in comparison to a Licensed Egg Derived, Split Virus, Seasonal Influenza…
- Trial name
- NCT00424086
- Testing
- Inactivated seasonal influenza vaccine (split virus, vero cell derived), Inactivated seasonal influenza vaccine (split virus, egg derived) [licensed control vaccine]
- Where
- 8 sites in Austria, Germany and 1 more
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Healthy
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clearance in healthy participants…
- Trial name
- NCT03261401
- Testing
- M5717
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatitis C
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy.
- Trial name
- PROMISE (NCT01281839)
- Testing
- TMC435, Peginterferon alpha-2a (PegIFN alpha-2a), Ribavirin (RBV)
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 394 people
- Sponsor
- Janssen R&D Ireland
Covid19
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
- Trial name
- NCT04532294
- Testing
- BGB DXP593
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- BeiGene
Hepatitis B, Chronic
Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of…
- Trial name
- NCT06000657
- Testing
- Vemliver tablet, Baracross Tablet
- Where
- South Korea
- Volunteers
- 196 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Chronic Hepatitis B
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are…
- Trial name
- NCT05414981
- Testing
- ABI-H3733
- Where
- 9 sites in Bulgaria, Hong Kong and 4 more
- Volunteers
- 31 people
- Sponsor
- Assembly Biosciences
Hepatitis C, Chronic
Open Label Trial to Compare BI 207127 to Telaprevir in HCV Patients
The aim of this trial is to evaluate efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD Faldaprevir and RBV compared to a Telaprevir-based regimen along with PegIFN and RBV in chronically…
- Trial name
- NCT01858961
- Testing
- BI 201335, ribavirin, BI 207127
- Where
- 12 sites in Australia, Spain and 1 more
- Sponsor
- Boehringer Ingelheim
Papillomavirus Infections
A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects
The purpose of this study is to evaluate the safety, tolerability, and the immunological effects of adeno-associated virus-like particle human papillomavirus (AAVLP-HPV) vaccine in healthy adults.
- Trial name
- NCT03929172
- Testing
- AAVLP-HPV
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- 2A Pharma AB
Influenza
Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children
A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.
- Trial name
- NCT01310400
- Testing
- Inflexal V, Agrippal
- Where
- China
- Volunteers
- 1,356 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Healthy Volunteer
TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers.
- Trial name
- NCT01288677
- Testing
- TMC649128
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis B, Chronic
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection
This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in…
- Trial name
- NCT02391805
- Testing
- Entecavir, RO6864018, Tenofovir
- Where
- 14 sites in Hong Kong, Malaysia and 4 more
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in…
- Trial name
- NCT03434353
- Testing
- Inarigivir Soproxil, TAF
- Where
- 13 sites in Hong Kong, South Korea
- Volunteers
- 123 people
- Sponsor
- Gilead Sciences
Influenza
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
- Trial name
- NCT07496450
- Testing
- mRNA-1018-H5
- Where
- 35 sites in United States, United Kingdom
- Volunteers
- 4,050 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days.
- Trial name
- NCT07601074
- Testing
- Lopinavir / ritonavir
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Daré Bioscience, Inc.
Hepatitis C, Chronic, Healthy Volunteer
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection.
- Trial name
- NCT01371162
- Testing
- RO5428029
- Where
- 6 sites in France, Netherlands and 1 more
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Influenza Immunization
Substudy 01 - Safety and Immunogenicity of One Monovalent Modified mRNA Vaccine Encoding Influenza Hemagglutinin With LNP, in Adult Participants Aged 18 to 49 Years and 60 Years and Above
This is a Phase 1, parallel, randomized, active-controlled, multi-center, dose-esclation study with a Master Protocol design which will include several substudies that are developed to evaluate the safety and immunogenicity of…
- Trial name
- NCT05829356
- Testing
- H3 mRNA / LNP Vaccine, Quadrivalent recombinant influenza Vaccine (RIV4)
- Where
- 8 sites in Australia, United Kingdom
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus
The purpose of this study is to determine the antiviral effects and safety of clevudine 30 mg once a day (QD) and 50 mg QD in patients infected with hepatitis B virus (HBV).
- Trial name
- NCT00305019
- Testing
- clevudine
- Where
- 8 sites in South Korea
- Volunteers
- 120 people
- Sponsor
- Bukwang Pharmaceutical