Clinical trials: Human Healthy Volunteers
Influenza
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
- Trial name
- NCT02148328
- Testing
- Trivalent virosomal influenza vaccine, Commercial vaccine 1, Quadrivalent virosomal influenza vaccine
- Where
- 4 sites in Belgium
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Healthy Volunteers
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers
This is a Phase 1, single-center, randomized, double-blind, active-controlled clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and nephrotoxicity attenuation potential of VRP-034 compared with…
- Trial name
- VRP-034 (NCT07502144)
- Testing
- VRP-034 (Polymyxin B 500,000 IU), Commercially available Polymyxin B 500,000 IU (Poly-MxB)
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Venus Remedies Limited
Psoriasis
Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers.
Single center, randomized, double-blind, placebo-controlled clinical study to assess the safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).
- Trial name
- ADENOIMMUNE (NCT03798236)
- Testing
- PBF-1650 oral capsules
- Where
- Spain
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Palobiofarma SL
HIV Infections
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4011499 in Healthy Participants
This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4011499 in healthy adults.
- Trial name
- NCT05393271
- Testing
- VH4011499, Midazolam
- Where
- 2 sites in United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi…
- Trial name
- NCT01630642
- Testing
- Torrent's Clopidogrel Tablets USP 75 mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
HIV (Human Immunodeficiency Virus)
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LP-98 Injection in Healthy Subjects
A randomized, placebo-controlled, single-administration, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of LP-98 injection in healthy subjects in a first-in-human clinical study
- Trial name
- NCT05933824
- Testing
- LP-98 injection
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shanxi Kangbao Biological Product Co., Ltd.
Influenza
Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects
The purpose of this study is to evaluate the safety and pharmacokinetic profile of flufirvitide-3 nasal spray in healthy subjects.
- Trial name
- NCT01313962
- Testing
- Flufirvitide-3 0.05 mg single dose, Flufirvitide-3, 0.1 mg single dose, Flufirvitide-3, 0.2 mg single dose
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Autoimmune Technologies, LLC
Neurodegenerative Diseases
A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of ONO-2808-01 in Healthy Participants
This is a first in human study to determine the safety, tolerability and pharmacokinetics of ONO-2808 in healthy adult participants.
- Trial name
- NCT04578028
- Testing
- ONO-2808
- Where
- United Kingdom
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Metabolic Processes
A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178
The study aims to assess the routes and the extent of metabolism and excretion of YM178 after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male volunteers.
- Trial name
- NCT01651312
- Testing
- 14C-labeled YM178
- Where
- Netherlands
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Chronic Hepatitis B Infection
Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
This is a Phase 1 non-randomized, open-label, single-dose study of pevifoscorvir sodium (also known as ALG-000184) in participants with severe renal impairment (Part 1), in participants with mild or moderate renal impairment…
- Trial name
- NCT07342881
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Healthy
Single Dose Study to Assess the Safety, Tolerability, Concentration in Body and Effect of BAF312
The purpose of this study is to assess the safety, tolerability, and effect of oral BAF312 on bodily functions as well as the body's absorption, distribution, metabolism, and excretion of BAF312 in healthy volunteers
- Trial name
- NCT00422175
- Testing
- BAF 312
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Novartis
Schizophrenia
A First In Human Study Of PF-00184562 In Healthy Volunteers
The purposes of this study are: To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and To explore the exposure-response relationship of neuropsychometric and tolerability measures of…
- Trial name
- NCT00150215
- Testing
- PF-00184562, Olanzapine
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Oral Doses Of PF-03716539 In Healthy Adult Subjects
First in human study to evaluate the safety, tolerability, and pharmacokinetics of PF-03716539. The potential of PF-03716539 to increase the concentrations of midazolam, darunavir and maraviroc will also be evaluated.
- Trial name
- NCT00783484
- Testing
- PF-03716539, Midazolam, Midazolam + PF-03716539 (100 mg)
- Where
- Belgium
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pfizer
Asthma
A Study to Evaluate the Safety and Use of Human Rhinovirus in Healthy and Asthmatic Participants (MK-0000-218)
The purpose of this study is to establish the safety and tolerability of Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes (U-BIOPRED) human rhinovirus 16 (RV16UB) in healthy and asthmatic participants, and…
- Trial name
- NCT01866306
- Testing
- RV16UB, LABA
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Safety and Tolerability in Healthy Volunteers
Safety and User Experience of BP-CBB
This study is the first-in human study for the food ingredient BP-CBB and aims aims to build on the excellent safety and tolerability observed in the extensive food safety assessment performed for BP-CBB, as well as the consumer…
- Trial name
- NCT07628608
- Testing
- BP-CBB
- Where
- Ireland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Parkinson Disease
WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects
The Phase 1 PK study is planned to evaluate the food effect on WD-1603 pharmacokinetics
- Trial name
- NCT04513340
- Testing
- WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS
- Where
- India
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Hong Kong WD Pharmaceutical Co., Limited
HIV-1
PEPI-TiDP23-C103: First-in-Human Study to Examine the Safety, Tolerability, and Plasma Pharmacokinetics of Increasing Single and Repeated Oral Doses of TMC558445 and of a Combined Single Day Dosing of Oral TMC558445 and Oral TMC310911 and Also Oral Darunavir
The purpose of the study is to determine the safety, tolerability and plasma pharmacokinetics (pk) (i.e., the levels of TMC558445 circulating in your blood over time) of increasing single oral doses of TMC558445 and of multiple…
- Trial name
- NCT00838760
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Chronic Kidney Disease
A Study to Evaluate the Safety and Pharmacokinetics With MEDI8367 Administered in Healthy Subjects, and in Subjects With Chronic Kidney Disease
This Phase I First in Human (FIH) study is being conducted to determine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity profile of MEDI8367 across the dose range.
- Trial name
- NCT04365218
- Testing
- MEDI8367
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Measles, Mumps
Immunogenicity and Safety of Concomitant Administration of MMR™ rHA and VARIVAX® by Intramuscular Versus Subcutaneous Route (V205C-011)
Primary objective: To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single…
- Conditions
- Measles, Mumps, Varicella
- Trial name
- NCT00432523
- Testing
- M-M-R™II manufactured with recombinant Human Albumin (rHA) and VARIVAX®
- Where
- 2 sites in France, Germany
- Volunteers
- 752 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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