Clinical trial NCT06877611: A Phase 1 Study of S-4321
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Seismic Therapeutic AU Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Avance Clinical Pty Ltd.
First posted: 2025-03-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

1. Is available for the entire duration of the study and follow up.
2. Is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
3. Voluntarily consents to participation in the trial as documented by signing the study informed consent form (ICF).
4. Has a body mass index (BMI) within 18 to 32 kg/m2, inclusive, and weighs ≥45 kg.
5. Is in good physical and mental health in the opinion of the Investigator or delegate.

Major Exclusion Criteria:

1. Has a history of severe allergic or anaphylactic reaction as determined by the Investigator or delegate.
2. Is pregnant, nursing, or is planning to become pregnant or breastfeed during the trial.
3. Has a known immunodeficiency disorder.
4. Has a history of malignancy or confirmed cervical dysplasia.
5. Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
6. Has positive laboratory evidence for active hepatitis at screening.
7. 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0
timeFrame: 2 months
Secondary outcomes:
measure: To assess the maximum serum concentration (CMAX)
timeFrame: 2 months
measure: To assess time to reach maximum serum concentration (tMAX)
timeFrame: 2 months
measure: To assess elimination half-life (t1/2)
timeFrame: 2 months
measure: To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)
timeFrame: 2 months
measure: To assess clearance (CL)
timeFrame: 2 months
measure: To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)
timeFrame: 2 months
measure: To assess bioavailability after SC administration (F%)
timeFrame: 2 months
measure: To characterize absolute change from baseline of Receptor Occupancy (RO) at multiple timepoints
timeFrame: 2 months
measure: Incidence and characterization of anti-drug antibody (ADA)
timeFrame: 2 months
Other outcomes:
Locations:
city: Bayswater
country: Australia
facility: Veritus Research
state: Victoria
Study officials:
References: