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

NCT05408572 | Completed Early Phase 1 DMC

• 1 other identifier: SB102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of SON-1010 as a single-ascending dose (SAD) in healthy adults.

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (5)

Single Dose Level 1

EXPERIMENTAL

6 healthy adults dosed with SON-1010 (Level 1) + 2 healthy adults dosed with Placebo

Biological: SON-1010 (IL12-FHAB)

Single Dose Level 2

EXPERIMENTAL

6 healthy adults dosed with SON-1010 (Level 2) + 2 healthy adults dosed with Placebo

Biological: SON-1010 (IL12-FHAB)

Single Dose Level 3

EXPERIMENTAL

6 healthy adults dosed with SON-1010 (Level 3) + 2 healthy adults dosed with Placebo

Biological: SON-1010 (IL12-FHAB)

Single Dose Level 4

EXPERIMENTAL

6 healthy adults dosed with SON-1010 (Level 4) + 2 healthy adults dosed with Placebo

Biological: SON-1010 (IL12-FHAB)

Single Dose Level 5

EXPERIMENTAL

6 healthy adults dosed with SON-1010 (Level 5) + 2 healthy adults dosed with Placebo

Biological: SON-1010 (IL12-FHAB)

Interventions

SON-1010 (IL12-FHAB) BIOLOGICAL

SON-1010 is a single-chain human IL-12 cytokine linked to a single-chain variable region known as the FHAB.

Single Dose Level 1; Single Dose Level 2; Single Dose Level 3; Single Dose Level 4; Single Dose Level 5

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be medically healthy based on medical history, physical examination, and clinical laboratory testing.
• Participants must be between 18 to 54 years of age, inclusive at the time of the informed consent.
• May only be limited users of nicotine-containing products, including e-cigarettes, for at least 3 continuous months before the first dose of SON-1010, as confirmed by cotinine testing at screening and check-in (day -1). Social smoking is allowed up to 5 cigarettes per week as long as the participant is willing to abstain during confinement and the cotinine test is negative at check in. One repeat test is permitted at screening.
• Must have negative drug/alcohol testing at screening and check-in (day -1). Screening drug/alcohol testing may be repeated once if deemed appropriate.
• Must have vital signs (after sitting for at least 5 minutes) within the following ranges at screening and check-in (day -1):
• Systolic blood pressure (BP), 90 to 140 mmHg, inclusive
• Diastolic BP, 40 to 90 mmHg, inclusive
• Heart rate (HR) \>50 to ≤100 beats per minute
• Must weigh \>50 kg and ≤100 kg and have body mass index (BMI) ≥18 and ≤32 kg/m2 at screening.
• Must have normal laboratory function by day -1 (note that the screening safety laboratory assessment may be repeated once to confirm the initial result and trending), defined as:
• Creatinine level ≤ upper limit of normal (ULN) for age
• Alanine aminotransferase (ALT) ≤ ULN
• Total bilirubin ≤ ULN (unless participant has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin and direct bilirubin is \<35%)
• Albumin \> lower limit of normal (LLN)
• Coagulation International Normalized Ratio (INR) \< 1.5

You may not qualify if:

• Concurrent conditions that could interfere with safety and/or tolerability measurements.
• Known history of allergy to any component of study intervention.
• History of severe allergic/anaphylactic reaction.
• Pregnancy and/or lactation
• Receipt of any plasma-, protein-, or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within 3 months before the first dose of study intervention. Note: Influenza and COVID-19 vaccines will be allowed if administered more than 14 days before the first dose of study intervention.
• Receipt of any investigational agent or treatment within 30 days or 5 half-lives, whichever is longer, before the first dose of study intervention.
• Any active infection, including COVID-19, as determined by the currently applicable standard before study intervention.
• Any acute noninfectious illness within 30 days before day 1.
• Diagnosis of or positive screening result for active COVID-19, hepatitis B surface antigen (HbsAg), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus (HIV)-1 or HIV-2 antibody.
• Unable or unwilling to cooperate with the Investigator for any reason.
• History of any clinically relevant or chronic psychiatric, renal, hepatic, cardiovascular, pancreatic, neurologic, hematologic, or gastrointestinal disease (e.g., inflammatory bowel disease) or current clinically significant liver function test results. Mild anxiety and depression may be acceptable at the investigator's discretion.
• Evidence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of study intervention. History of cholecystectomy is acceptable.
• Presence of clinically significant electrocardiogram (ECG) finding (confirmed upon repeat testing) that may interfere with any aspect of study conduct or interpretation of results, as follows:
• QT interval corrected for HR according to Fridericia's formula (QTcF) \> 450 in males or \> 470 msec in females at screening or check-in (day -1).
• Other ECG abnormalities clinically relevant in the judgment of the Investigator.

Sponsors & Collaborators

• Sonnet BioTherapeutics: lead

Study Sites (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• Kenney RT, Cini JK, Dexter S, DaFonseca M, Bingham J, Kuan I, Chawla SP, Polasek TM, Lickliter J, Ryan PJ. A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers. Front Immunol. 2024 Feb 29;15:1362775. doi: 10.3389/fimmu.2024.1362775. eCollection 2024.

  PMID: 38487528 DERIVED

Study Officials

• Richard Kenney, MD

  Sonnet BioTherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: July 27, 2022
• Primary Completion: February 28, 2023
• Study Completion: May 17, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)