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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07903493




Registration number
Help: Registration number
NCT07903493
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
18/10/2026
Date registered
Help: Date registered
29/10/2026
Date last updated
Help: Date last updated
3/11/2026

Titles & IDs
Public title
Phase Ia Study of MST-931 in Healthy Adult Subjects
Scientific 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
Additional trial identifiers [1] 0 0
MST-931-HV-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Ankylosing Spondylitis (AS) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Other - MST-931
Treatment: Other - MST-931 Placebo

Experimental: MST-931 dose level 1 treatment Cohort - MST-931 dose level 1

Experimental: MST-931 dose level 2 treatment Cohort - MST-931 dose level 2

Experimental: MST-931 dose level 3 treatment Cohort - MST-931 dose level 3

Experimental: MST-931 dose level 4 treatment Cohort - MST-931 dose level 4

Placebo comparator: Matching placebo for each dose group - Matching placebo


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

Treatment: Other: MST-931 Placebo
Matching placebo for MST-931
Intervention code [1] 0 0
Treatment: Other
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of subjects with drug related adverse events (AEs)
Timepoint [1] 0 0
Through study completion, up to 113 days
Secondary outcome [1] 0 0
PK parameters for MST-931: Area Under Curve (AUC)
Timepoint [1] 0 0
Through study completion, up to 113 days
Secondary outcome [2] 0 0
PK parameters for MST-931: Maximum Observed Concentration (Cmax)
Timepoint [2] 0 0
Through study completion, up to 113 days
Secondary outcome [3] 0 0
PK parameters for MST-931: Time of maximum observed concentration (Tmax)
Timepoint [3] 0 0
Through study completion, up to 113 days
Secondary outcome [4] 0 0
PK parameters for MST-931: Elimination Half-life (t1/2)
Timepoint [4] 0 0
Through study completion, up to 113 days

Eligibility
Key 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. Body Mass Index (BMI) = 18 and = 32 kg/m².
3. Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.
4. Signed Informed consent form for participation in the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
* Subjects who meet any of the following criteria will be excluded from study entry

1. Hypersensitivity to the Investigational Medicinal Product (IMP) or any of its components, to biological agents, or prior history of severe drug hypersensitivity reactions.
2. 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.
3. 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.
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mabsoft Therapeutics (Shanghai) Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Mabsoft Therapeutics (Australia) Pty. Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Mabsoft Therapeutics (Guangdong Hengqin) Co., Ltd.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Changlong Liu
Address 0 0
Country 0 0
Phone 0 0
+86-15810213012
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07903493