A Phase 1 Study of S-4321

Seismic Therapeutic AU Pty Ltd

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: S-4321; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877611

S-4321-101

Details and patient eligibility

About

This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Full 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).

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

S-4321 Part 1: Single ascending dose (SAD) cohorts

Experimental group

Treatment:

Other: Placebo

Drug: S-4321

S-4321 Part 2: Multiple ascending dose (MAD) cohorts

Experimental group

Treatment:

Other: Placebo

Drug: S-4321