Official Title
Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants
Brief Summary

The purpose of this study is to investigate the safety, tolerability, andpharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI inhealthy adults.

Detailed Description

Not Provided

Recruiting
Healthy Participants

Drug: S-892216-LAI

S-892216-LAI injection will be administered per schedule specified in the arm
description.

Drug: Placebo

S-892216-LAI matching placebo injection will be administered per schedule specified in
the arm description.

Eligibility Criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

- 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.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Eligibility Gender
Male
Eligibility Age
Minimum: 18 Years ~ Maximum: 55 Years
Countries
United States
Locations

ICON Clinical Research: Lenexa
Lenexa, Kansas, United States

ICON Clinical Research: Salt Lake City
Salt Lake City, Utah, United States

Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line
800-849-9707
Shionogiclintrials-admin@shionogi.co.jp

Not Provided

NCT Number
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