Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • S-4321

    Drug

    S-4321 via subcutaneous or intravenous administration

  • Placebo

    Other intervention

    Placebo via subcutaneous or intravenous administration.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: S-4321 Part 1: Single ascending dose (SAD) cohortsExperimental treatment 2 interventions
Group B: S-4321 Part 2: Multiple ascending dose (MAD) cohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0

Time frame
2 months

Secondary outcomes

1

To assess the maximum serum concentration (CMAX)

Time frame
2 months
2

To assess time to reach maximum serum concentration (tMAX)

Time frame
2 months
3

To assess elimination half-life (t1/2)

Time frame
2 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seismic Therapeutic AU Pty Ltd

Lead sponsor

Avance Clinical Pty Ltd.

Collaborator

Source ClinicalTrials.gov
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