Healthy ParticipantsPhase 1NCT07093580
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
A Phase 1 study testing S-892216-LAI in people with Healthy Participants, run by Shionogi at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- S-892216-LAI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jul 2025to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)
Who cannot join
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
- History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Require medication or other treatment (for example, dietary restrictions or physical therapy).
- Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
- Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
- 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.
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- Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.
- Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
United States3 sites, 1 recruiting
- Recruiting
Altasciences
Cypress, California, 90630
- Active, not recruiting
ICON Clinical Research: Lenexa
Lenexa, Kansas, 66219
- Active, not recruiting
ICON Clinical Research: Salt Lake City
Salt Lake City, Utah, 84124
About this study
Official title: Phase 1 Study of a Long-acting Injectable S-892216 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.
- Conditions
- Healthy Participants
- Being tested
- S-892216-LAI, Placebo
- Keywords
- First-in-human (FIH), Long-acting injectable (LAI) formulation, S-892216, S-892216-LAI, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2 infection, Novel Coronavirus, Coronavirus Disease 2019, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-892216-LAIDrug
S-892216-LAI injection will be administered per schedule specified in the arm description.
PlaceboDrug
Physiological saline will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Participants will receive a single dose of S-892216-LAI or placebo on Day 1. Receives: Drug: S-892216-LAI; Drug: Placebo |
| Part 2 (Multiple Ascending Dose) | Experimental | Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively. Receives: Drug: S-892216-LAI; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 through Day 364
Part 2: Number of Participants With TEAEs
Measured: Day 1 through Day 448
Secondary outcomes (6)
Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Cmax of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Tmax of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: AUC0-last of S-892216 and its Metabolites
Measured: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start29 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093580
- Sponsor's protocol ID
- 2316T1711
- Other IDs
- RRPV-24-03-SmMol-001
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07093580
- Acronym / sponsor ID
- 2316T1711
- Conditions
- Healthy Participants
- Keywords
- First-in-human (FIH), Long-acting injectable (LAI) formulation, S-892216, S-892216-LAI, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2 infection, Novel Coronavirus, Coronavirus Disease 2019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Drug: S-892216-LAI, Drug: PlaceboParticipants will receive a single dose of S-892216-LAI or placebo on Day 1. |
| Part 2 (Multiple Ascending Dose) | Experimental | Drug: S-892216-LAI, Drug: PlaceboParticipants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)
Key exclusion criteria (9 listed)
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
- History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Require medication or other treatment (for example, dietary restrictions or physical therapy).
- Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
- Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-892216-LAIS-892216-LAI injection will be administered per schedule specified in the arm description. | Drug | Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) |
| PlaceboPhysiological saline will be administered per schedule specified in the arm description. | Drug | Part 1 (Single Ascending Dose), Part 2 (Multiple Ascending Dose) |
Primary outcome
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 364
Part 2: Number of Participants With TEAEs
Time frame: Day 1 through Day 448
6 secondary outcomes
Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Cmax of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Tmax of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: AUC0-last of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing S-892216-LAI in people with Healthy Participants, run by Shionogi at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shionogi Clinical Trials Administrator Clinical Support Help Line (800-849-9707, Shionogiclintrials-admin@shionogi.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 through Day 364). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.