Healthy Participants study: S-892216-LAI
Official title Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07093580
What this study is testing
What is S-892216-LAI?
S-892216-LAI is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy participants.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether the drug is safe and well‑tolerated, and to measure how it is absorbed, distributed, and cleared after one or several doses.
- Who it's for
- Healthy adult volunteers.
- What's involved
- Participants receive a single injection or a series of injections of S‑892216‑LAI and undergo safety checks and blood draws to track the drug in their bodies.
- Time commitment
- The trial lasts several weeks to a few months and includes multiple clinic visits for dosing and follow‑up assessments.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)
You likely can't join if
- Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or...
- History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease...
- 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...
- Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen...
- Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive...
See the full eligibility 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...
- 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...
- 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)
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Cypress, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cypress, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.