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RecruitingNCT07903493Updated Nov 3, 2026

Phase Ia Study of MST-931 in Healthy Adult Subjects

A Phase 1 interventional study of MST-931 and MST-931 Placebo in Ankylosing Spondylitis (AS), sponsored by Mabsoft Therapeutics (Shanghai) Co., Ltd.. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Mabsoft Therapeutics (Shanghai) Co., Ltd. · Phase 1, Interventional, and Other

Updated Nov 3, 2026Now RecruitingFirst site in Australia+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

A Phase 1a, randomized, double-blind study of MST-931 in healthy participants.

The purpose of this research is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous dose of MST-931 given to healthy participants. MST-931 is a monoclonal antibody.

02

Conditions studied

  • Ankylosing Spondylitis (AS)

Keywords

  • ankylosing spondylitis
03

In context

Spondylitis, Ankylosing

531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.

This study's planned enrollment of 32 is below the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Mabsoft Therapeutics (Shanghai) Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must meet the following criteria to be eligible for study entry:

    1. Healthy male or female subjects age ≥ 18 and ≤ 55 years.
    2. (BMI) ≥ 18 and ≤ 32 kg/m².
    3. Normal , blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not .
    4. Signed form for participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from study entry

    1. to the Medicinal Product (IMP) or any of its components, to biological agents, or prior history of severe drug hypersensitivity reactions.
    2. History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunologic, dermatologic, psychiatric or neurological disease, or other significant clinical findings within 3 months before screening.
    3. History of within 5 years prior to screening, with the exception of patients with a negligible risk of or death and/or treated with expected curative outcome.
    4. Family history of premature Coronary Heart Disease.
    5. Pregnant or Breastfeeding subject, women with positive pregnancy test (hCG).
    6. Unlikely to comply with the clinical study protocol.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    MST-931 dose level 1 treatment Cohort

    MST-931 dose level 1

    Biological: MST-931

  • Experimental
    MST-931 dose level 2 treatment Cohort

    MST-931 dose level 2

    Biological: MST-931

  • Experimental
    MST-931 dose level 3 treatment Cohort

    MST-931 dose level 3

    Biological: MST-931

  • Experimental
    MST-931 dose level 4 treatment Cohort

    MST-931 dose level 4

    Biological: MST-931

  • Placebo comparator
    Matching placebo for each dose group

    Matching placebo

    Biological: MST-931 Placebo

Interventions

  • BiologicalMST-931

    MST-931 is a proprietary monoclonal antibody developed by Mabsoft Therapeutics.

  • BiologicalMST-931 Placebo

    Matching placebo for MST-931

06

What researchers measure

Primary outcomes

  1. Percentage of subjects with drug related adverse events (AEs)

    Time frame: Through study completion, up to 113 days

Secondary outcomes

  1. PK parameters for MST-931: Area Under Curve (AUC)

    Time frame: Through study completion, up to 113 days

  2. PK parameters for MST-931: Maximum Observed Concentration (Cmax)

    Time frame: Through study completion, up to 113 days

  3. PK parameters for MST-931: Time of maximum observed concentration (Tmax)

    Time frame: Through study completion, up to 113 days

  4. PK parameters for MST-931: Elimination Half-life (t1/2)

    Time frame: Through study completion, up to 113 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 3, 2026
Sites
1 site added — first site in Australia
Show site
  • Q-Pharm Pty Ltd · Herston, Australia
Nov 3, 2026
Registered
First appeared on the registry
Oct 29, 2026
Show all 2 updates
  1. Nov 3, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Australia
    Show site
    • Q-Pharm Pty Ltd · Herston, Australia
  2. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07903493
Lead sponsor
Mabsoft Therapeutics (Shanghai) Co., Ltd.
Collaborators
Mabsoft Therapeutics (Australia) Pty. Ltd., Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Changlong Liu
Contact
changlong.liu@mabsoftbio.com
+86-15810213012

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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