Ankylosing Spondylitis (AS)Phase 1NCT07903493
Phase Ia Study of MST-931 in Healthy Adult Subjects
A Phase 1 study testing MST-931 in people with Ankylosing Spondylitis (AS), run by Mabsoft Therapeutics (Shanghai) Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis (AS)
- What is being tested?
- MST-931
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Nov 2026to 30 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet the following criteria to be eligible for study entry:
- Healthy male or female subjects age ≥ 18 and ≤ 55 years.
- Body Mass Index (BMI) ≥ 18 and ≤ 32 kg/m².
- Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
- Signed Informed consent form for participation in the study.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from study entry
- Hypersensitivity to the Investigational Medicinal Product (IMP) or any of its components, to biological agents, or prior history of severe drug hypersensitivity reactions.
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immunologic, dermatologic, psychiatric or neurological disease, or other significant clinical findings within 3 months before screening.
- History of malignancy within 5 years prior to screening, with the exception of patients with a negligible risk of metastases or death and/or treated with expected curative outcome.
- Family history of premature Coronary Heart Disease.
- Pregnant or Breastfeeding subject, women with positive pregnancy test (hCG).
- Unlikely to comply with the clinical study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Q-Pharm Pty Ltd
Herston, Queensland, 4006
Richard Friend, Doctor, 0737072720, R.friend@nucleusnetwork.com.au
About this study
Official title: A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MST-931 in Healthy Adult Subjects
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.
- Conditions
- Ankylosing Spondylitis (AS)
- Being tested
- MST-931, MST-931 Placebo
- Keywords
- ankylosing spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MST-931Biological
MST-931 is a proprietary monoclonal antibody developed by Mabsoft Therapeutics.
MST-931 PlaceboBiological
Matching placebo for MST-931
| Study group | Role | What they receive |
|---|---|---|
| MST-931 dose level 1 treatment Cohort | Experimental | MST-931 dose level 1 Receives: Biological: MST-931 |
| MST-931 dose level 2 treatment Cohort | Experimental | MST-931 dose level 2 Receives: Biological: MST-931 |
| MST-931 dose level 3 treatment Cohort | Experimental | MST-931 dose level 3 Receives: Biological: MST-931 |
| MST-931 dose level 4 treatment Cohort | Experimental | MST-931 dose level 4 Receives: Biological: MST-931 |
| Matching placebo for each dose group | Placebo comparator | Matching placebo Receives: Biological: MST-931 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with drug related adverse events (AEs)
Measured: Through study completion, up to 113 days
Secondary outcomes (4)
PK parameters for MST-931: Area Under Curve (AUC)
Measured: Through study completion, up to 113 days
PK parameters for MST-931: Maximum Observed Concentration (Cmax)
Measured: Through study completion, up to 113 days
PK parameters for MST-931: Time of maximum observed concentration (Tmax)
Measured: Through study completion, up to 113 days
PK parameters for MST-931: Elimination Half-life (t1/2)
Measured: Through study completion, up to 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabsoft Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mabsoft Therapeutics (Australia) Pty. Ltd., Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903493
- Sponsor's protocol ID
- MST-931-HV-101
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MST-931 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07903493
- Acronym / sponsor ID
- MST-931-HV-101
- Conditions
- Ankylosing Spondylitis (AS)
- Keywords
- ankylosing spondylitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Mabsoft Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Mabsoft Therapeutics (Australia) Pty. Ltd., Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MST-931 dose level 1 treatment Cohort | Experimental | Biological: MST-931MST-931 dose level 1 |
| MST-931 dose level 2 treatment Cohort | Experimental | Biological: MST-931MST-931 dose level 2 |
| MST-931 dose level 3 treatment Cohort | Experimental | Biological: MST-931MST-931 dose level 3 |
| MST-931 dose level 4 treatment Cohort | Experimental | Biological: MST-931MST-931 dose level 4 |
| Matching placebo for each dose group | Placebo comparator | Biological: MST-931 PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must meet the following criteria to be eligible for study entry:
Key exclusion criteria (7 listed)
- Subjects who meet any of the following criteria will be excluded from study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MST-931MST-931 is a proprietary monoclonal antibody developed by Mabsoft Therapeutics. | Biological | MST-931 dose level 1 treatment Cohort, MST-931 dose level 2 treatment Cohort, MST-931 dose level 3 treatment Cohort, MST-931 dose level 4 treatment Cohort |
| MST-931 PlaceboMatching placebo for MST-931 | Biological | Matching placebo for each dose group |
Primary outcome
Percentage of subjects with drug related adverse events (AEs)
Time frame: Through study completion, up to 113 days
4 secondary outcomes
PK parameters for MST-931: Area Under Curve (AUC)
Time frame: Through study completion, up to 113 days
PK parameters for MST-931: Maximum Observed Concentration (Cmax)
Time frame: Through study completion, up to 113 days
PK parameters for MST-931: Time of maximum observed concentration (Tmax)
Time frame: Through study completion, up to 113 days
PK parameters for MST-931: Elimination Half-life (t1/2)
Time frame: Through study completion, up to 113 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MST-931 in people with Ankylosing Spondylitis (AS), run by Mabsoft Therapeutics (Shanghai) Co., Ltd. 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changlong Liu (+86-15810213012, changlong.liu@mabsoftbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with drug related adverse events (AEs) (time frame: Through study completion, up to 113 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.