Clinical trials: Healthy Adult Subjects
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
Healthy
A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants
The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese…
- Trial name
- NCT03123848
- Testing
- Darunavir/Cobicistat
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy
An Interaction Study to Assess Drug Levels in Healthy Adult Subjects
To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir.
- Trial name
- NCT00614991
- Testing
- Raltegravir, Fosamprenavir, Ritonavir
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Garden State Infectious Disease Associates, PA
Healthy Volunteers
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in…
- Trial name
- NCT03918239
- Testing
- SHP643
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Shire
Zika Virus
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
- Trial name
- NCT03014089
- Testing
- mRNA-1325
- Where
- 3 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Herpes Zoster
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course.
- Trial name
- NCT02735915
- Testing
- Herpes Zoster Vaccine GSK1437173A
- Where
- 7 sites in Czechia, Germany and 1 more
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Insomnia
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
- Trial name
- NCT00291187
- Testing
- 20 mg VEC-162, 50 mg VEC-162, 100 mg VEC-162
- Where
- 19 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Healthy Volunteers
Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls (esomeprazole and rabeprazole sodium) in healthy…
- Trial name
- NCT02037477
- Testing
- Vonoprazan, Esomeprazole, Rabeprazole sodium
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Adult Male
Evaluation Study of the Bioavailability of Brexpiprazole Orally Disintegrating Tablets in Healthy Male Subjects
The ratios of the geometric means of the ODT formulation to those of the reference formulation (conventional tablet) for the bioavailability variables (Cmax, AUCt, and AUC∞ of brexpiprazole (OPC-34712)).
- Trial name
- NCT02875080
- Testing
- OPC-34712
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy
A Study of Selpercatinib (LY3527723) in Healthy Participants
The main purpose of this study is to determine how safe and how well tolerated selpercatinib is when given as oral doses to healthy participants.
- Trial name
- NCT05338515
- Testing
- Selpercatinib
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Rabies, Japanese Encephalitis
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure…
- Trial name
- NCT01662440
- Testing
- Rabies, Japanese Encephalitis
- Where
- 3 sites in Austria, Germany and 1 more
- Volunteers
- 661 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Prophylaxis: Influenza
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and…
- Trial name
- NCT02256488
- Testing
- TIVc_LOT A, TIVc_LOT B, TIVc_LOT C
- Where
- 24 sites in United States
- Volunteers
- 1,561 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Healthy Volunteers
Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants
The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.
- Trial name
- NCT05134337
- Testing
- LOXO-305, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
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
Dengue
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60…
- Trial name
- NCT03342898
- Testing
- YF-17D, TDV
- Where
- 11 sites in United States
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Takeda
Influenza
A Phase 1/2 Study of a Intramuscular Injection of TAK-850 in Healthy Adult Subjects
This clinical trial is a phase 1/2 study of a single intramuscular injection of TAK-850 in healthy Japanese adult participants
- Trial name
- NCT02111252
- Testing
- TAK-850
- Where
- Japan
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants
The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it…
- Trial name
- NCT06181006
- Testing
- Pirtobrutinib
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.
- Trial name
- NCT01979185
- Testing
- Simvastatin, SSP-004184SS
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy
A Study of Single and Multiple Doses of ALXN1210 in Healthy, Adult Japanese Participants
This study evaluated the safety and tolerability of single and multiple doses (400 and 800 milligrams [mg]) of ALXN1210 following intravenous administration to healthy Japanese participants.
- Trial name
- NCT05288816
- Testing
- ALXN1210
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.