S-892216-LAI for Healthy Adults

Recruiting at 1 trial location

Overseen By Shionogi Clinical Trials Administrator Clinical Support Help Line

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Shionogi

Disqualifiers: Cardiovascular, Cancer, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called S-892216-LAI (an experimental treatment) to assess its safety and how the body processes it. The research involves administering either a single dose or multiple doses to healthy adults, with some participants receiving a placebo for comparison. It suits individuals who are generally healthy, have a body mass index (BMI) between 18.5 and 32, and lack major health issues that might affect drug absorption or processing. Participants should not have a history of serious illnesses like cancer or be on medications that could interfere with the study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that participants do not need any medication or other treatments, so you would need to stop taking your current medications to participate.

Is there any evidence suggesting that S-892216-LAI is likely to be safe for humans?

Research has shown that S-892216-LAI is being developed as a potential long-acting treatment for COVID-19. Although limited data exists on this specific treatment, it is important to note that this is a Phase 1 study, indicating the treatment is in the early stages of human testing.

At this stage, the primary goal is to assess how well participants tolerate the treatment and to identify any side effects. Treatments reaching this phase have typically shown promise in lab and animal tests, but detailed safety information may not yet be available.

For S-892216-LAI, no major side effects have been reported so far. However, as the study is still in its early stages, further research is necessary to confirm its safety in humans. Prospective participants should discuss any concerns with the study team, who can provide the most current information and assist in determining if this trial is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

S-892216-LAI is unique because it introduces a new formulation designed for extended release, potentially improving convenience and adherence compared to standard treatments that require more frequent dosing. While most treatments require regular administration, S-892216-LAI offers both single and multiple ascending dose options, possibly providing flexibility in managing treatment plans. Researchers are excited because this could lead to more consistent therapeutic effects with fewer doses, which might enhance patient compliance and overall outcomes.

What evidence suggests that S-892216-LAI could be effective?

Studies have shown that S-892216 has strong effects against viruses. In lab tests, it successfully blocked an important part of the virus, showing promise against different types of coronavirus. Early trials suggested it could work as a long-lasting treatment, potentially reducing the frequency of doses. This trial will evaluate S-892216-LAI, with participants receiving either a single dose or multiple doses in different study arms. This indicates that S-892216 could help reduce the impact of COVID-19. However, more research is needed to understand its effects in people. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to participate in a study testing the safety of a new long-acting injectable drug, S-892216-LAI. The specifics about who can join are not provided here, but typically participants must meet certain health standards.

Inclusion Criteria

Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)

Exclusion Criteria

Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission

Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI

I have used tobacco, nicotine products, or cannabis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive a single dose of S-892216-LAI or placebo on Day 1

1 day

1 visit (in-person)

Multiple Ascending Dose

Participants receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• S-892216-LAI

Trial Overview The trial is examining how safe and tolerable the drug S-892216-LAI is when given once or multiple times to healthy people. It also looks at how the body processes the drug. Some will receive the actual drug while others will get a placebo for comparison.

How Is the Trial Designed?

Group I: Part 2 (Multiple Ascending Dose) Experimental Treatment 2 Interventions

Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.

Group II: Part 1 (Single Ascending Dose) Experimental Treatment 2 Interventions

Participants will receive a single dose of S-892216-LAI or placebo on Day 1.

Who Is Running the Clinical Trial?

Shionogi

Lead Sponsor

Trials

122

Recruited

42,100+

Dr. Isao Teshirogi

Shionogi

Chief Executive Officer since 2008

PhD in Pharmaceutical Sciences from the University of Tokyo

Dr. Takuko Sawada

Shionogi

Chief Medical Officer since 2022

MD from a recognized institution (specific details not found)

Citations

1. shionogi.com shionogi.com/us/en/news/2025/01/shionogi-receives-award-through-bardas-rapid-response-partnership-vehicle-to-advance-long-acting-formulation-of-s-892216-an-antiviral-for-covid-19-pre-exposure-prophylaxis-in-at-risk-populations.html

Shionogi Receives Award Through BARDA's Rapid ... In pre-clinical trials, S-892216 demonstrated a strong antiviral effect. S-892216 was discovered by Shionogi and its research and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06928051

A Study of S-892216 in Participants With COVID-19 The primary objective of this study is to investigate the antiviral effect of S-892216 in participants with coronavirus disease 2019 (COVID-19) due to ...

3. withpower.com withpower.com/trial/phase-1-covid-19-6-2025-67ab6

S-892216-LAI for Healthy Adults 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11778574/

P-1079. In Vitro and in Vivo Antiviral Activity of S-892216, a ... Results. S-892216 showed high 3CLpro inhibitory activity (IC50 = 0.697 nmol/L) and exhibited in vitro antiviral activity against several SARS- ...

5. researchgate.net researchgate.net/publication/394416683_Novel_Approach_to_Pre-Exposure_Prophylaxis_PrEP_of_COVID-19_Development_of_S-892216_Long-Acting_Injectable_Suspension

Development of S-892216 Long-Acting Injectable ... LAI formulations can achieve sustained drug release for extended periods of time, which results in less frequent dosing requirements leading ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-s-892216-long-acting-injectable-lai-in-healthy-adult-participants

Study of S-892216 Long-acting Injectable (LAI) in Healthy ... The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration ...