NCT05408572

Study of SON-1010 (IL12-FHAB) in Healthy Adults

A Phase 1, Randomized, Adaptive-Design, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Healthy Adults

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sonnet BioTherapeutics · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult

Interventions

Type	Name	Description
BIOLOGICAL	SON-1010 (IL12-FHAB)	SON-1010 is a single-chain human IL-12 cytokine linked to a single-chain variable region known as the FHAB.

Timeline

• Start date: 2022-07-27
• Primary completion: 2023-02-28
• Completion: 2023-05-17
• First posted: 2022-06-07
• Last updated: 2023-09-06

Locations

1 site across 1 country: Australia