Healthy VolunteersPhase 1NCT07799025
Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects
A Phase 1 study testing MWX203 S1, MWX203 S2 and MWX203 S3 in people with Healthy Volunteers, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MWX203 S1, MWX203 S2 and MWX203 S3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2025to Jan 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
- Healthy male and female subjects aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF).
- Fasting serum LDL-C ≥ 2.6 mmol/L (100 mg/dL) and < 4.1 mmol/L (158 mg/dL), and fasting triglycerides ≥ 1.1 mmol/L (100 mg/dL) and < 5.7 mmol/L (500 mg/dL) at screening; no lipid-regulating drugs used within the past 3 months.
- Body mass index (BMI) from 19.0 to 30.0 kg/m², inclusive, at screening; male subjects must have a body weight ≥ 50.0 kg and female subjects must have a body weight ≥ 45.0 kg.
- Stable diet and physical-activity habits for 4 weeks prior to screening; no major changes to diet or exercise are planned during the study, and participants will not follow any weight-loss plan.
- Subjects or their partners have no plans for pregnancy, sperm donation, or egg donation from the time of signing the ICF until at least 6 months after dosing, and agree to use medically-recognized, effective non-pharmacological contraceptive methods throughout the study.
- Voluntarily participate in the study; able to read, understand, and sign the ICF before study participation; willing to comply with the study protocol and expected to complete the study.
Who cannot join
- Any infectious disease within 4 weeks prior to screening (as judged by the investigator to affect the subject's ability to participate in the study).
- Serious trauma or major surgery (requiring general anesthesia) within 6 months prior to screening, or planned major surgery during the study.
- At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin > 1.5 × ULN; serum creatinine > 1.2 × ULN; or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² (calculated using the CKD-EPI equation, Appendix 4).
- QTcF ≥ 450 ms (male) or ≥ 470 ms (female) at screening; or clinically-significant abnormalities on the 12-lead electrocardiogram.
- HbA1c > ULN.
- Overall atherosclerotic cardiovascular disease (ASCVD) risk assessed by the investigator as moderate or high risk at screening.
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- Use of any liver-targeted oligonucleotide drug within 1 year prior to screening.
- Pregnant or lactating female subjects at screening.
- Difficult venous access, difficult subcutaneous injection, or intolerance to repeated venipuncture; or clinically significant needle phobia or blood phobia history as judged by the investigator.
- Use of any over-the-counter medications, prescription medications, traditional Chinese medicine, vitamins, or health supplements within 2 weeks prior to screening or within 5 half-lives of any prior medication (whichever is longer).
- Receipt of any live vaccine, live attenuated vaccine, or vaccines containing live viral components within 3 months prior to screening or planned vaccination during the study.
- Any other condition judged by the investigator to make the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Administration of MWX203 Injection in Healthy Chinese Subjects
This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects.
The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).
- Conditions
- Healthy Volunteers
- Being tested
- MWX203 S1, Placebo, MWX203 S2, MWX203 S3, MWX203 S4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWX203 S1Drug
administered subcutaneously (SC)
PlaceboDrug
administered SC
MWX203 S2Drug
administered SC.
MWX203 S3Drug
administered SC.
MWX203 S4Drug
administered SC.
MWX203 S5Drug
administered SC.
MWX203 S6Drug
administered SC.
| Study group | Role | What they receive |
|---|---|---|
| MWX203 Cohort 1 | Experimental | Escalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: MWX203 S1; Drug: Placebo |
| MWX203 Cohort 2 | Experimental | Escalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: Placebo; Drug: MWX203 S2 |
| MWX203 Cohort 3 | Experimental | Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: Placebo; Drug: MWX203 S3 |
| MWX203 Cohort 4 | Experimental | Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: Placebo; Drug: MWX203 S4 |
| MWX203 Cohort 5 | Experimental | Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: Placebo; Drug: MWX203 S5 |
| MWX203 Cohort 6 | Experimental | Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. Receives: Drug: Placebo; Drug: MWX203 S6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) and serious adverse events (SAEs).
Measured: Through study completion, for at least 85 days
Secondary outcomes (13)
Maximum Concentration (Cmax)
Cmax of MWX203.
Measured: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Tmax of MWX203.
Measured: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWX203.
Measured: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWX203.
Measured: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWX203.
Measured: Up to 48 hours post-dose
Terminal Elimination Rate Constant (λz)
λz of MWX203.
Measured: Up to 48 hours post-dose
Apparent Oral Clearance (CL/F)
CL/F of MWX203.
Measured: Up to 48 hours post-dose]
Apparent Volume of Distribution (Vd/F)
Vd/F of MWX203.
Measured: Up to 48 hours post-dose
Mean Residence Time (MRT)
MRT of MWX203.
Measured: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Ae of MWX203.
Measured: Up to 48 hours post-dose
Fraction of Dose Excreted in Urine (Fe)
Fe of MWX203.
Measured: Up to 48 hours post-dose
Renal Clearance (CLr)
CLr of MWX203.
Measured: Up to 48 hours post-dose
Anti-Drug Antibody (ADA)
ADA of MWX203.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start7 Jul 2025
- Primary completion7 Mar 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799025
- Sponsor's protocol ID
- MWX203-I
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Subcutaneous Administration of MWX203 Injection in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07799025
- Acronym / sponsor ID
- MWX203-I
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 7 Mar 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Sep 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.
This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects.
The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MWX203 Cohort 1 | Experimental | Drug: MWX203 S1, Drug: PlaceboEscalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers. |
| MWX203 Cohort 2 | Experimental | Drug: Placebo, Drug: MWX203 S2Escalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers. |
| MWX203 Cohort 3 | Experimental | Drug: Placebo, Drug: MWX203 S3Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. |
| MWX203 Cohort 4 | Experimental | Drug: Placebo, Drug: MWX203 S4Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. |
| MWX203 Cohort 5 | Experimental | Drug: Placebo, Drug: MWX203 S5Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. |
| MWX203 Cohort 6 | Experimental | Drug: Placebo, Drug: MWX203 S6Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF).
- Fasting serum LDL-C ≥ 2.6 mmol/L (100 mg/dL) and < 4.1 mmol/L (158 mg/dL), and fasting triglycerides ≥ 1.1 mmol/L (100 mg/dL) and < 5.7 mmol/L (500 mg/dL) at screening; no lipid-regulating drugs used within the past 3 months.
- Body mass index (BMI) from 19.0 to 30.0 kg/m², inclusive, at screening; male subjects must have a body weight ≥ 50.0 kg and female subjects must have a body weight ≥ 45.0 kg.
- Stable diet and physical-activity habits for 4 weeks prior to screening; no major changes to diet or exercise are planned during the study, and participants will not follow any weight-loss plan.
- Subjects or their partners have no plans for pregnancy, sperm donation, or egg donation from the time of signing the ICF until at least 6 months after dosing, and agree to use medically-recognized, effective non-pharmacological contraceptive methods throughout the study.
Key exclusion criteria (12 listed)
- Any infectious disease within 4 weeks prior to screening (as judged by the investigator to affect the subject's ability to participate in the study).
- Serious trauma or major surgery (requiring general anesthesia) within 6 months prior to screening, or planned major surgery during the study.
- At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin > 1.5 × ULN; serum creatinine > 1.2 × ULN; or estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² (calculated using the CKD-EPI equation, Appendix 4).
- QTcF ≥ 450 ms (male) or ≥ 470 ms (female) at screening; or clinically-significant abnormalities on the 12-lead electrocardiogram.
- HbA1c > ULN.
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 |
|---|---|---|
| MWX203 S1administered subcutaneously (SC) | Drug | MWX203 Cohort 1 |
| Placeboadministered SC | Drug | MWX203 Cohort 1, MWX203 Cohort 2, MWX203 Cohort 3, MWX203 Cohort 4, MWX203 Cohort 5, MWX203 Cohort 6 |
| MWX203 S2administered SC. | Drug | MWX203 Cohort 2 |
| MWX203 S3administered SC. | Drug | MWX203 Cohort 3 |
| MWX203 S4administered SC. | Drug | MWX203 Cohort 4 |
| MWX203 S5administered SC. | Drug | MWX203 Cohort 5 |
| MWX203 S6administered SC. | Drug | MWX203 Cohort 6 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Through study completion, for at least 85 days
The incidence of adverse events (AEs) and serious adverse events (SAEs).
13 secondary outcomes
Maximum Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
Time frame: Up to 48 hours post-dose
Terminal Elimination Rate Constant (λz)
Time frame: Up to 48 hours post-dose
Apparent Oral Clearance (CL/F)
Time frame: Up to 48 hours post-dose]
Apparent Volume of Distribution (Vd/F)
Time frame: Up to 48 hours post-dose
Mean Residence Time (MRT)
Time frame: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Time frame: Up to 48 hours post-dose
Fraction of Dose Excreted in Urine (Fe)
Time frame: Up to 48 hours post-dose
Renal Clearance (CLr)
Time frame: Up to 48 hours post-dose
Anti-Drug Antibody (ADA)
Time frame: Up to Day 85
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 2 Sep 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 MWX203 S1, MWX203 S2 and MWX203 S3 in people with Healthy Volunteers, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 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 China. 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?
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?
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?
Incidence of adverse events (AEs) (time frame: Through study completion, for at least 85 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 2 Sep 2026.