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Recruiting

NCT Number: NCT06828393

A Phase 1 Study of S-1117

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

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location status: Recruiting

Location contact

CMAX Contact

CONTACT

[email protected]

1800 150 433

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Major Inclusion Criteria:

  • 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.
  • Is in good physical and mental health in the opinion of the Investigator or delegate.

Major Exclusion Criteria:

  • 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 other than non-melanoma skin cancer.
  • Has a history of human immunodeficiency virus (HIV) or positive serology for HIV at Screening.
  • Has positive laboratory evidence for active hepatitis at screening.
  • Has received a live vaccine within 2 months of Screening.
  • 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.

Treatment and study plan

S-1117

Drug

S-1117 via subcutaneous or intravenous administration.

Placebo

Other

Placebo via subcutaneous or intravenous administration.

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

  5. To assess clearance (CL)

    Time frame: 2 months

  6. To assess volume of distribution (Vz) and steady-state volume of distribution (Vss)

    Time frame: 2 months

  7. To assess bioavailability after SC administration (F%)

    Time frame: 2 months

  8. To characterize absolute and proportional change from baseline of immunoglobulin G (IgG) at multiple timepoints

    Time frame: 2 months

  9. Incidence and characterization of antidrug antibody (ADA)

    Time frame: 2 months

Study contacts

Contact information is provided by the study sponsor or research team.

Seismic Contact

CONTACT

[email protected]

1800 244 475

Sponsors and collaborators

Lead sponsor

Seismic Therapeutic AU Pty Ltd

Industry

Collaborators

  • Avance Clinical Pty Ltd.

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-1117 in Healthy Volunteers

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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