A Phase 1 Study of S-4321
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSeismic Therapeutic AU Pty Ltd
About this trial
This is the first-in-human study of S-4321 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- S-4321
- Placebo
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Seismic Therapeutic AU Pty Ltd
Lead sponsor
Avance Clinical Pty Ltd.
Collaborator
Source ClinicalTrials.gov