Healthy VolunteersPhase 1NCT07787611
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
A Phase 1 study testing MWN109 tablet 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, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MWN109 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2025to 20 Dec 2025
- Phase
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form).
- Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female).
- Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization.
Who cannot join
- History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis, or amylase or lipase > 1.5 times the upper limit of normal (ULN) at screening.
- Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels.
- Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months).
- History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months.
- History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study.
- Any of the following abnormal laboratory findings at screening: a) fasting blood glucose ≥ 7.0 mmol/L or < 3.9 mmol/L, or HbA1c > 6.5%; b) estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m²; c) triglycerides (TG) ≥ 5.65 mmol/L.
- Blood donation, significant blood loss (> 400 mL), or receipt of blood transfusion within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Meal Timing Effects Following Single and Multiple Oral Administration of MWN109 Tablets in Chinese Study Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants.
The study consists of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. The SAD part includes 6 dose cohorts, with further evaluation of the effects of different meal-timing conditions at a selected dose level. The MAD part includes 4 dose cohorts administered with once-daily or every-other-day dosing regimens for up to 4 weeks.
Approximately 108 healthy participants aged 18 to 50 years are planned to be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.
- Conditions
- Healthy Volunteers
- Being tested
- MWN109 tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN109 tabletDrug
A1, A2, A3a, A3b, A3c, A4; administered orally
MWN109 tabletDrug
B1, B2, B3, B4; administered orally
PlaceboDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| MWN109 Cohort A | Experimental | MWN109 Cohort A consists of 6 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo under fasted or fed conditions. Receives: Drug: MWN109 tablet; Drug: Placebo |
| MWN109 Cohort B | Experimental | MWN109 Cohort B consists of 4 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo once daily for a total of 4 weeks of treatment. Receives: Drug: MWN109 tablet; Drug: Placebo |
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: From Day 1 to Day 42
Secondary outcomes (12)
Maximum Concentration (Cmax)
Cmax of MWN109 and its excipient, salcaprozate sodium (SNAC).
Measured: From Day 1 to Day 15
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 15
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 15
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 15
Elimination Half-Life (t1/2)
t1/2 of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 15
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Steady State Minimum Concentration (Cmin,ss)
Cmin,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Steady State Concentration (Cav,ss)
Cav,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
AUC0-τ,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN109 and its excipient, SNAC.
Measured: From Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start27 Jun 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 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
- NCT07787611
- Sponsor's protocol ID
- MWN109 Oral-I
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 26 Aug 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Meal Timing Effects Following Single and Multiple Oral Administration of MWN109 Tablets in Chinese Study Participants
- ClinicalTrials.gov ID
- NCT07787611
- Acronym / sponsor ID
- MWN109 Oral-I
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 26 Aug 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, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants.
The study consists of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. The SAD part includes 6 dose cohorts, with further evaluation of the effects of different meal-timing conditions at a selected dose level. The MAD part includes 4 dose cohorts administered with once-daily or every-other-day dosing regimens for up to 4 weeks.
Approximately 108 healthy participants aged 18 to 50 years are planned to be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWN109 Cohort A | Experimental | Drug: MWN109 tablet, Drug: PlaceboMWN109 Cohort A consists of 6 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo under fasted or fed conditions. |
| MWN109 Cohort B | Experimental | Drug: MWN109 tablet, Drug: PlaceboMWN109 Cohort B consists of 4 dose groups. In all dose groups, healthy participants are randomized to receive oral MWN109 tablets or placebo once daily for a total of 4 weeks of treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form).
- Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female).
- Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization.
Key exclusion criteria (8 listed)
- History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution.
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis, or amylase or lipase > 1.5 times the upper limit of normal (ULN) at screening.
- Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels.
- Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months).
- History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months.
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 |
|---|---|---|
| MWN109 tabletA1, A2, A3a, A3b, A3c, A4; administered orally | Drug | MWN109 Cohort A |
| MWN109 tabletB1, B2, B3, B4; administered orally | Drug | MWN109 Cohort B |
| Placeboadministered orally | Drug | MWN109 Cohort A, MWN109 Cohort B |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From Day 1 to Day 42
The incidence of adverse events (AEs) and serious adverse events (SAEs).
12 secondary outcomes
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 15
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 15
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 15
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 15
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 15
Steady State Maximum Concentration (Cmax,ss)
Time frame: From Day 1 to Day 42
Steady State Minimum Concentration (Cmin,ss)
Time frame: From Day 1 to Day 42
Steady State Concentration (Cav,ss)
Time frame: From Day 1 to Day 42
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame: From Day 1 to Day 42
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame: From Day 1 to Day 42
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame: From Day 1 to Day 42
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame: From Day 1 to Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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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. 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 MWN109 tablet 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 3 inclusion and 8 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 26 Aug 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?
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?
Incidence of adverse events (AEs) (time frame: From Day 1 to Day 42). 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 26 Aug 2026.