A Phase 1 Study of S-1117

NCT ID: NCT06828393

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-03-31

Brief Summary

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

Detailed Description

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).

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

S-1117 Part 1: Single ascending dose (SAD) cohorts

Group Type: EXPERIMENTAL

S-1117

Intervention Type: DRUG

S-1117 via subcutaneous or intravenous administration.

Placebo

Intervention Type: OTHER

Placebo via subcutaneous or intravenous administration.

S-1117 Part 2: Multiple ascending dose (MAD) cohorts

Group Type: EXPERIMENTAL

S-1117

Intervention Type: DRUG

S-1117 via subcutaneous or intravenous administration.

Placebo

Intervention Type: OTHER

Placebo via subcutaneous or intravenous administration.

Interventions

S-1117

S-1117 via subcutaneous or intravenous administration.

Intervention Type: DRUG

Placebo

Placebo via subcutaneous or intravenous administration.

Intervention Type: OTHER

Eligibility 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.

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.

Other inclusion/exclusion eligibility criteria apply.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avance Clinical Pty Ltd.

INDUSTRY

Sponsor Role: collaborator

Seismic Therapeutic AU Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMAX Clinical Research

Adelaide, South Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Seismic Contact

Role: CONTACT

clinical@seismictx.com

1800 244 475

Facility Contacts

CMAX Contact

Role: primary

cmax@cmax.com.au

1800 150 433

Other Identifiers

S-1117-101

Identifier Type: -

Identifier Source: org_study_id