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Healthy AdultEarly Phase 1NCT05408572

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

A Early Phase 1 study testing SON-1010 (IL12-FHAB) in people with Healthy Adult, run by Sonnet BioTherapeutics at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 54 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult
What is being tested?
SON-1010 (IL12-FHAB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteAustralia
Study dates
27 Jul 2022to 17 May 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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
  • Females of childbearing potential, <1-year postmenopause who are not permanently sterile, must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-HCG]) at day -1, and agree to abstinence or use 2 highly effective methods of birth control for 30 days before the study, during the study, and for 30 days after the last dose of study intervention. Females who are not of childbearing potential (have had a hysterectomy, bilateral oophorectomy, or are ≥ 1-year postmenopause) do not need to use any contraception Nonchildbearing potential is defined as surgically sterile or postmenopausal (defined as 12 months of spontaneous amenorrhea). A follicle stimulating hormone (FSH) level >40 IU/L at screening will confirm postmenopausal status. If a participant is not sexually active, but becomes active, then she and her male partner must use 2 methods of adequate contraception.
  • Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential and must not donate sperm during the study and for 90 days after the last dose of study intervention. Contraception guidance is described in the protocol.
  • Willing and able to provide signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Must be able to communicate well with Investigator and/or study site personnel and to comply with the requirements of the entire study.

Who cannot join

  • 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.
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  • 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.
  • Use of any prescription or over-the-counter medications (apart from standard doses of analgesics), herbal products (e.g., St. John's Wort, garlic supplements, milk thistle), topical or inhaled steroids, or supplements/vitamins within 7 days before the first dose of SON-1010 and for the duration of the study, except for those approved by the Investigator and Sponsor (e.g., oral contraceptives, hormone replacement therapy).
  • Recent use of systemic steroids within 14 days of enrollment, except for physiologic doses for steroid replacement. Limited doses of systemic steroids (e.g., in patients with exacerbation of reactive airway disease) must have been completed at least 10 days before enrollment.
  • Use of biotin (i.e. Vitamin B7) or supplemental biotin higher than the daily adequate intake of 30 μg (FDA 2019). Patients who switch from a high dose to a dose of 30 μg/day or less are eligible.
  • History of alcohol or substance abuse within 6 months before the first dose of SON-1010 per the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
  • History of any major surgery within 3 months before the first dose of study intervention.
  • Donation or receipt of blood or blood product within 3 months before the first dose of SON-1010 and for the duration of the study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network Pty Ltd

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: 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

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.

Read the 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
Being tested
SON-1010 (IL12-FHAB)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05408572
Study groupRoleWhat they receive
Single Dose Level 1Experimental6 healthy adults dosed with SON-1010 (Level 1) + 2 healthy adults dosed with Placebo
Receives: Biological: SON-1010 (IL12-FHAB)
Single Dose Level 2Experimental6 healthy adults dosed with SON-1010 (Level 2) + 2 healthy adults dosed with Placebo
Receives: Biological: SON-1010 (IL12-FHAB)
Single Dose Level 3Experimental6 healthy adults dosed with SON-1010 (Level 3) + 2 healthy adults dosed with Placebo
Receives: Biological: SON-1010 (IL12-FHAB)
Single Dose Level 4Experimental6 healthy adults dosed with SON-1010 (Level 4) + 2 healthy adults dosed with Placebo
Receives: Biological: SON-1010 (IL12-FHAB)
Single Dose Level 5Experimental6 healthy adults dosed with SON-1010 (Level 5) + 2 healthy adults dosed with Placebo
Receives: Biological: SON-1010 (IL12-FHAB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (3)

  1. Serum and urine concentrations of SON-1010 will be determined at various time points

    Concentration vs time of SON-1010 will be measured using blood \& urine samples taken at various time points on study

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

  2. Effect of SON-1010 on Serum cytokine levels

    Concentration of serum level of IL-2, IL-6, IL-10 will be measured using blood samples taken at various time points on study

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

  3. Evaluation of SON-1010 immunogenicity

    Evaluate the immunogenicity of SON-1010 by measuring the number of patients developing anti-SON-1010 antibodies

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study start27 Jul 2022
  3. Primary completion28 Feb 2023
  4. Study completion17 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408572
Sponsor's protocol ID
SB102
Status last verified
Sep 2023
First submitted
1 Jun 2022
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38487528

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SON-1010 (IL12-FHAB) in people with Healthy Adult, run by Sonnet BioTherapeutics at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of SON-1010 as a single-ascending dose (SAD) in healthy adults. (time frame: Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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