Clinical trials: open to volunteers, sponsored by Shionogi
SARS-CoV-2
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
- Trial name
- NCT07743580
- Testing
- Secutrelvir
- Where
- 51 sites in United States, Bulgaria and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Shionogi
Respiratory Syncytial Virus Infections
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention…
- Trial name
- NCT07214571
- Testing
- S-337395
- Where
- 89 sites in United States, Argentina and 6 more
- Volunteers
- 192 people
- Sponsor
- Shionogi
Healthy Participants
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
- Trial name
- NCT07093580
- Testing
- S-892216-LAI
- Where
- 3 sites in United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Shionogi
Pompe Disease
An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)
The primary purpose of this study is to evaluate the long-term safety and tolerability profile of S-606001 in participants with LOPD.
- Trial name
- NCT07750990
- Testing
- S-606001, ERT
- Volunteers
- 60 people
- Sponsor
- Shionogi
Renal Impairment
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal…
- Trial name
- NCT07857837
- Testing
- Sulthiame
- Where
- 2 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
COVID-19
Study of Secutrelvir in Participants With COVID-19
The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of…
- Trial name
- NCT07746544
- Testing
- Secutrelvir
- Where
- Japan
- Volunteers
- 1,200 people
- Sponsor
- Shionogi
Pompe Disease
A Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD)
The primary purpose of this study is to evaluate the safety and tolerability profile of S-606001 in participants with LOPD.
- Trial name
- NCT07787650
- Testing
- S-606001
- Volunteers
- 15 people
- Sponsor
- Shionogi
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Pompe Disease
Study of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and exploratory clinical efficacy of S-606001 in adult participants with LOPD as an add-on to ERT.
- Trial name
- NCT07123155
- Testing
- S-606001
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 45 people
- Sponsor
- Shionogi
Solid Tumors
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011 with or without pembrolizumab.
- Trial name
- aCCeleR8-001 (NCT05101070)
- Testing
- S-531011, Pembrolizumab, Bevacizumab
- Where
- 8 sites in United States, Japan
- Volunteers
- 282 people
- Sponsor
- Shionogi