A Phase 1 Study of S-4321
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: S-4321, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers
Overview
This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
Detailed description
This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of S-4321 administered to healthy adult participants. This study will be conducted in two parts, Part 1 (single ascending dose, SAD) and Part 2 (multiple ascending doses, MAD).
Interventions
- Drug S-4321
S-4321 via subcutaneous or intravenous administration - Other Placebo
Placebo via subcutaneous or intravenous administration.
Primary outcome measures
- Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0 [Time frame: 2 months]
Secondary outcome measures (9)
- To assess the maximum serum concentration (CMAX) [Time frame: 2 months]
- To assess time to reach maximum serum concentration (tMAX) [Time frame: 2 months]
- To assess elimination half-life (t1/2) [Time frame: 2 months]
- To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf) [Time frame: 2 months]
- To assess clearance (CL) [Time frame: 2 months]
- To assess volume of distribution (Vz) and steady-state volume of distribution (Vss) [Time frame: 2 months]
- To assess bioavailability after SC administration (F%) [Time frame: 2 months]
- To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints [Time frame: 2 months]
- Incidence and characterization of anti-drug antibody (ADA) [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Is available for the entire duration of the study and follow up.
- Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
- Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
- Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
- Is in good physical and mental health in the opinion of the Investigator or delegate.
Major Exclusion Criteria:
- Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
- Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
- Has a known immunodeficiency disorder.
- Has a history of malignancy or confirmed cervical dysplasia.
- Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
- Has positive laboratory evidence for active hepatitis at screening.
- Has any other condition or prior therapy that, in the opinion of the Investigator or delegate, may potentially compromise the safety or compliance of the participant, or may preclude the participant from successfully completing the study.
Other inclusion/exclusion eligibility criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Veritus Research — Bayswater
Identifiers
NCT: NCT06877611 · S-4321-101