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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy Adult

Clinical Trial Details

NCT number	NCT05408572
Study type	Interventional
Source	Sonnet BioTherapeutics
Contact
Status	Completed
Phase	Early Phase 1
Start date	July 27, 2022
Completion date	May 17, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02257151` - Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects	Phase 1
Completed	`NCT06169059` - To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004	Phase 1
Completed	`NCT06165965` - To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008	Phase 1
Completed	`NCT01506739` - A Bioequivalence Study of Film-coated Tablet and Dry Syrup 1% Form for E2020 in Healthy Japanese Adult Males	Phase 1
Completed	`NCT00400309` - Safety of REPEVAX® Given One Month After REVAXIS®	Phase 3
Completed	`NCT04027218` - Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.	N/A
Not yet recruiting	`NCT04964245` - Respiratory Measurement of Volume Change Using Accelerometer, Thermographic Camera Electrical Impedance Tomography and Motion Correlation Analysis Using Mattress Sensor in Healthy Individuals	N/A
Completed	`NCT01506752` - A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males	Phase 1
Completed	`NCT03827005` - L-arginine Supplementation and Resistance Exercise	N/A
Completed	`NCT05688566` - Biomechanical Characteristics of Lower Extremity During Pinnacle Trainer With Different Pedal Angles	N/A
Completed	`NCT06171880` - To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901	Phase 1
Completed	`NCT01274130` - Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers	N/A
Withdrawn	`NCT04762823` - Multiple Sessions of Transcranial Direct Current Stimulation in People With Parkinson's Disease	N/A
Recruiting	`NCT06385639` - Efficacy and Safety of Probiotic Products for Digestive Health	N/A
Not yet recruiting	`NCT06344533` - Study of JMKX003142 Injection in Chinese Healthy Subjects	Phase 1