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A Phase 1 Study of S-1117

PHASE1RECRUITING

This is the first-in-human study of S-1117 designed to provide safety, tolerability, pharmacokinetic, and pharmacodynamic data in healthy volunteers.

Study details:

This is a randomized, placebo-controlled, double-blind, study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of S-1117 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

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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 other than non-melanoma skin cancer.
  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 received a live vaccine within 2 months of Screening.
  8. 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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06828393

Intervention or treatment

DRUG: S-1117

OTHER: Placebo

Conditions

  • Healthy Volunteer

  • Condition: Healthy Volunteer

  • DRUG: S-1117 and other drugs

  • Adelaide, South Australia, Australia

  • Sponsor: Seismic Therapeutic AU Pty Ltd

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

CMAX Clinical Research

Select from list below to view details:

  • CMAX Clinical Research

    Adelaide, South Australia, Australia

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Who is running the clinical trial?

STAPL

Seismic Therapeutic AU Pty Ltd

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: S-1117 Part 1: Single ascending dose (SAD) cohorts
  • Not Specified
Drug: S-1117, Other: Placebo
    EXPERIMENTAL: S-1117 Part 2: Multiple ascending dose (MAD) cohorts
    • Not Specified
    Drug: S-1117, Other: Placebo

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Number of participants with treatment-related adverse and serious adverse events as assessed by CTCAE v5.0Not Specified2 months

      Secondary Outcome

      MeasureDescriptionTime Frame
      To assess the maximum serum concentration (CMAX)Not Specified2 months
      To assess time to reach maximum serum concentration (tMAX)Not Specified2 months
      To assess elimination half-life (t1/2)Not Specified2 months
      To assess area under the serum concentration-time curve from time 0 to t hours (AUC0-t) and to infinity (AUC0-inf)Not Specified2 months
      To assess clearance (CL)Not Specified2 months
      To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)Not Specified2 months
      To assess bioavailability after SC administration (F%)Not Specified2 months
      To characterize absolute and proportional change from baseline of immunoglobulin G (IgG) at multiple timepointsNot Specified2 months
      Incidence and characterization of antidrug antibody (ADA)Not Specified2 months
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: A Phase 1 Study of S-1117

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