Clinical trials: Cohort Study
FXI
Single Ascending Dose of FXI-GalNAc-siRNA in Healthy Subjects
The purpose of this study is to evaluate safety, tolerability, PK, and PD of SAD of FXI-GalNAc-siRNA administered SC to healthy subjects.
- Trial name
- NCT05844293
- Testing
- FXI-GalNAc-siRNA
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sirnaomics
Healthy Volunteers
A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804
The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.
- Trial name
- NCT01479647
- Testing
- PH-797804
- Where
- Singapore
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Delirium, Delirium Drug-Induced
Estimation of Delirium Data Completeness
Currently physicians and nurses rely on their own clinical skills and experience to diagnose and record 'delirium' in the Electronic Health Records (EHR).
- Conditions
- Delirium, Delirium Drug-Induced, Delirium Confusional State, Delirium, Cause Unknown
- Trial name
- NCT04084821
- Testing
- none - observation only
- Where
- Israel
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Efficacy Care R&D Ltd
Healthy Volunteers in Fed and Fasted State
Pharmacokinetics of Zelquistinel in Fasted or Fed State
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers.
- Trial name
- GATE-251 (NCT07099989)
- Testing
- Zelquistinel 3 mg, Zelquistinel 10 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Syndeio Biosciences, Inc
COVID-19
Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above
This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months.
- Trial name
- COVID-19 (NCT05382871)
- Testing
- BIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), WIBP Omicron Inactivated COVID-19 vaccine (Vero Cell), COVID-19 Vaccine (Vero Cell), Inactivated
- Where
- Hong Kong
- Volunteers
- 1,804 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
Hepatic Impairment
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a…
- Trial name
- NCT05582187
- Testing
- Fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Pain
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants.
- Trial name
- NCT05737069
- Testing
- Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen)
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- HALEON
Musculoskeletal Pain
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
- Trial name
- NCT03193593
- Testing
- EB-001
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Bonti, Inc.
Dengue
A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
- Trial name
- NCT02570152
- Testing
- Blood sample collection
- Where
- Sri Lanka
- Volunteers
- 2,004 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cervical Disc Disease
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in…
- Trial name
- NCT07287449
- Testing
- Triadyme-C
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Dymicron
Healthy Volunteers
First-in-human: Single Ascending Dose, Food Effect, Drug-drug Interaction, Multiple Ascending Dose, Proof of Pharmacology
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of ASP6282 in healthy male and female subjects.
- Trial name
- NCT02420782
- Testing
- ASP6282, Itraconazole, Pilocarpine
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Healthy Volunteers
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL via local subcutaneous infiltration in healthy volunteers.
- Trial name
- NCT02210247
- Testing
- EXPAREL
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pacira Pharmaceuticals, Inc
Cardiovascular Disease
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
The objectives of this study are to look at the safety and tolerability of the experimental drug, how people process the drug, how the drug affects people, and to identify a dose or doses to study in subsequent future studies.
- Trial name
- NCT00099450
- Testing
- INS50589 Intravenous Infusion
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
First-in-Human Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of Janus Kinase-1 Inhibitor PF-04965842 in Healthy Western and Japanese Subjects
This single- and multiple-ascending dose study is the first evaluation of PF-04965842, a Janus kinase1 (JAK1) inhibitor, in humans.
- Trial name
- NCT01835197
- Testing
- PF-04965842
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dengue, Dengue Vaccines
This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.
- Trial name
- NCT02766088
- Testing
- Blood sample collection
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 1,750 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Schizophrenia
First Time in Human Study With GSK1018921
GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921 differs from other available drugs in its mode of action and it is assumed that it may have an effect in the treatment of so-called…
- Trial name
- NCT00527020
- Testing
- GSK1018921, Nicotine Lozenges
- Where
- Germany
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type II Diabetes
A Study to Assess the Bioequivalence of Fixed Dose Combination of HR20033 Relative to Co-administration of the Individual Components in Healthy Chinese Subjects
The trial is to assess the bioequivalence between HR20033 FDC tablet and co-administration of SHR3824 tablets and metformin XR tablets.
- Trial name
- NCT05108350
- Testing
- T1: FDC 5/500 mg; R1+R: SHR3824 5 mg + Metformin 500 mg XR, T2: FDC 5/1000 mg; R2+R: SHR3824 5 mg + two Metformin 500 mg XR
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Infertile Women Undergoing IVF or ICSI
Observational Study to Develop Dosing Chart
To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.
- Trial name
- NCT04227171
- Where
- South Korea
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)
This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.
- Trial name
- NCT02223117
- Testing
- Thrombosomes
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Cellphire Therapeutics, Inc.