Study of SON-1010 (IL12-FHAB) in Healthy Adults
- Conditions
- Healthy Adult
- Interventions
- Biological: SON-1010 (IL12-FHAB)
- Registration Number
- NCT05408572
- Lead Sponsor
- Sonnet BioTherapeutics
- Brief Summary
SB102 is a randomized, double-blind, single center, placebo-controlled study in healthy adults starting with sentinel participants at each dose level to carefully assess the safety, tolerability, PK, and PD of SON-1010.
- Detailed Description
This is a study of SON-1010, a single-chain human Interleukin-12 (IL12) cytokine linked to a single-chain variable region (scFv) antibody fragment, known as the fully human albumin binding domain (FHAB). The albumin binding domain moiety of SON-1010 attaches to albumin in the bloodstream, resulting in significantly enhanced drug PK properties, potentially lower risk than IL12 alone, and a broader therapeutic index. Healthy volunteers will be assessed with single ascending doses of SON-1010. The design comprises up to 5 separate dosing cohorts, with a total of 8 participants (minimum of 7) in each cohort randomized to receive either SON-1010 (6 participants) or placebo (2 participants), for up to 40 participants.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Single Dose Level 3 SON-1010 (IL12-FHAB) 6 healthy adults dosed with SON-1010 (Level 3) + 2 healthy adults dosed with Placebo Single Dose Level 2 SON-1010 (IL12-FHAB) 6 healthy adults dosed with SON-1010 (Level 2) + 2 healthy adults dosed with Placebo Single Dose Level 5 SON-1010 (IL12-FHAB) 6 healthy adults dosed with SON-1010 (Level 5) + 2 healthy adults dosed with Placebo Single Dose Level 1 SON-1010 (IL12-FHAB) 6 healthy adults dosed with SON-1010 (Level 1) + 2 healthy adults dosed with Placebo Single Dose Level 4 SON-1010 (IL12-FHAB) 6 healthy adults dosed with SON-1010 (Level 4) + 2 healthy adults dosed with Placebo
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of SON-1010 as a single-ascending dose (SAD) in healthy adults. Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method Serum and urine concentrations of SON-1010 will be determined at various time points Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29 Concentration vs time of SON-1010 will be measured using blood \& urine samples taken at various time points on study
Evaluation of SON-1010 immunogenicity Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29 Evaluate the immunogenicity of SON-1010 by measuring the number of patients developing anti-SON-1010 antibodies
Effect of SON-1010 on Serum cytokine levels Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29 Concentration of serum level of IL-2, IL-6, IL-10 will be measured using blood samples taken at various time points on study
Trial Locations
- Locations (1)
Nucleus Network Pty Ltd
🇦🇺Melbourne, Victoria, Australia