Clinical trials: Human Volunteers
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.
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
The primary objective of the study is to assess the safety and tolerability of single oral doses of GC021109 when administered to healthy adult subjects.
- Trial name
- NCT02254369
- Testing
- GC021109
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- GliaCure, Inc.
Idiopathic Pulmonary Fibrosis, Lung; Disease, Interstitial, With Fibrosis
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of RSN0402 in Healthy Volunteers
This is a phase 1, randomized, First in Human (FIH), double-blinded, placebo-controlled study to assess the safety, tolerability, and PK of RSN0402 in healthy volunteers.
- Trial name
- NCT06482190
- Testing
- RSN0402 Part 1, RSN0402 Part 2
- Where
- 3 sites in Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shenzhen Resproly Biopharmaceutical Co., Ltd
Hepatitis B, Chronic
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety…
- Trial name
- NCT02952924
- Testing
- Midazolam, RO7049389
- Where
- 21 sites in Australia, Bulgaria and 6 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Parkinson Disease
Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
No clinical trials with PBF-509 in humans have been performed to date. Only preclinical studies have been done to assess the pharmacology and pharmacokinetics, the safety and the toxicological profile of the PBF-509.
- Trial name
- NCT01691924
- Testing
- PBF-509
- Where
- 2 sites in Spain
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Healthy
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations…
- Trial name
- NCT01004770
- Testing
- GE-145 (AN113111) Injection, Visipaque (iodixanol) Injection
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Coronavirus
First-in-human Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Coronavirus Vaccine Candidate in Healthy Volunteers
This first-in-human clinical trial is designed to evaluate the safety and immunogenicity of one administration of OVX033 coronavirus vaccine at different dose levels (100µg, 250µg and 500µg)
- Trial name
- NCT06128382
- Testing
- OVX033, Saline solution
- Where
- France
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Osivax
Healthy Volunteer, Atopic Dermatitis
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B).
- Trial name
- AURA-AD (NCT07527923)
- Testing
- REGN20423
- Where
- 7 sites in United States, Belgium
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Healthy Volunteers
Spire Health Remote Patient Monitor Human Factors Summative Study Protocol
This usability validation testing protocol outlines the methods being used to demonstrate and gather evidence that the current design and user experience of the Spire Remote Patient Monitor are safe and effective for use by the…
- Trial name
- NCT06395350
- Testing
- Spire Health Monitor
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Spire, Inc.
HIV Infections
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter…
- Trial name
- NCT05418868
- Testing
- Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I
- Where
- 3 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteer, Female, Breast
Effect of Denosumab on Cellular Biomarkers in the Human Breast
To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
- Trial name
- NCT02099461
- Testing
- Denosumab, Percutaneous core needle breast biopsy
- Where
- 3 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Amgen
Influenza in Humans
A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872
This open-label, four group, fixed-sequence study will evaluate the safety and pharmacokinetic interaction of AL-794 on oseltamivir, JNJ-63623872 (formerly VX-787) and probes for P-glycoprotein, CYP3A and OATP1B1 in healthy…
- Trial name
- NCT02888327
- Testing
- AL-794, Oseltamivir, Digoxin
- Where
- United Kingdom
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Infection, Human Immunodeficiency Virus
GSK706769 Repeat Dose Study
To determine safety, tolerability and Pharmacokinetics of GSK706769
- Trial name
- NCT00711386
- Testing
- GSK706769
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Celiac Disease, Healthy
A First-in-human Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease
The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults. It will also look at how the body processes the drug.
- Trial name
- NCT07063823
- Testing
- HB-2121
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Nielsen Fernandez-Becker
Healthy Volunteers
Effect of Broccoli Sprout on Blood Levels of Sulforaphane to Reduce Responsiveness of Immune System
The investigators suggest that inducing anti-oxidant enzymes indirectly may be an effective means of providing vascular protection.
- Trial name
- NCT01357070
- Testing
- Brocco-sprout homogenate, Alfalfa sprout homogenate
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Ebola Virus Infection
Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802
Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.
- Trial name
- NCT02041715
- Testing
- TKM-100802 for Injection
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Arbutus Biopharma Corporation
Coronavirus
COV-CHIM01: SARS-CoV-2 (COVID-19) Dose Finding Infection Study
A phase I, experimental dose finding, open label, clinical infection, safety and viral detection optimisation in previously SARS-CoV-2 infected (unvaccinated or vaccinated) or uninfected vaccinated volunteers.
- Trial name
- NCT04864548
- Testing
- SARS-CoV-2 virus
- Where
- 3 sites in United Kingdom
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Autoimmune Diseases, Multiple Sclerosis
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
- Trial name
- NCT05853835
- Testing
- LPX-TI641
- Where
- 2 sites in United States, Jordan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- LAPIX Therapeutics Inc.
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fed Condition
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg [Test formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram…
- Trial name
- NCT01996475
- Testing
- Escitalopram Oxalate Tablets
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited