RECRUITING

Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants

Conditions

Healthy Participants 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants

Quick Facts

Study Start:2025-07-29

Study Completion:2027-05-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07093580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)	* 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. * 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.

Inclusion Criteria

Exclusion Criteria

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

* 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.
* 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.

Contacts and Locations

Study Contact

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

800-849-9707

Shionogiclintrials-admin@shionogi.co.jp

Study Locations (Sites)

ICON Clinical Research: Lenexa

Lenexa, Kansas, 66219

United States

ICON Clinical Research: Salt Lake City

Salt Lake City, Utah, 84124

United States

Collaborators and Investigators

Sponsor: Shionogi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-29

Study Completion Date2027-05-26

Study Record Updates

Study Start Date2025-07-29

Study Completion Date2027-05-26

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Healthy Participants