Healthy VolunteersPhase 1NCT07787624
Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers
A Phase 1 study testing MWN109 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- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MWN109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2024to 20 Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3.
- Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 19.0 to 28.0 kg/m^2 (inclusive).
- From the time of signing the informed consent form (ICF) until 3 months after the last dose, participants must have no plans to become pregnant or to father a child, must agree to use effective contraceptive measures to prevent pregnancy or causing a partner to become pregnant, and must have no plans to donate sperm or eggs.
Who cannot join
- History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 Injection) or severe atopic allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (allergy to two or more foods or drugs) (by inquiry).
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury or other high-risk factors that may lead to pancreatitis, or serum amylase > 1.5 × upper limit of normal (ULN) at screening (by inquiry and examination).
- Family history or history of medullary thyroid C-cell tumor/carcinoma; history of thyroid dysfunction or abnormal thyroid hormone levels (by inquiry).
- History or presence at screening of digestive system diseases that may increase the risk to volunteers, such as pancreatitis, abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction, etc.), or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months) (by inquiry).
- History of infectious diseases (which, in the investigator's assessment, may significantly affect the safety evaluation of volunteers) or severe trauma within 4 weeks before screening, or major surgery within 3 months before screening (by inquiry and examination).
- Use of any prescription or over-the-counter drug (including chemical drugs, vitamins, herbal medicines, etc.) within 2 weeks before dosing (by inquiry and examination);
- History of substance abuse (by inquiry).
- Blood donation or massive blood loss (> 400 mL) or blood transfusion within 3 months before screening (by inquiry).
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 1a Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Dose Escalation of MWN109 Injection in Healthy Chinese Volunteers
This is a randomized, double-blind, placebo-controlled, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials.
The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen.
Approximately 58 volunteers will 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, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWN109Drug
S1, S2 S3, S4; administered subcutaneously (SC)
MWN109Drug
M1, M2, M3; administered SC
PlaceboDrug
administered SC
| Study group | Role | What they receive |
|---|---|---|
| MWN109 S | Experimental | MWN109 Cohort S consists of 4 dose groups. Healthy volunteers in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN109 or placebo. Receives: Drug: MWN109; Drug: Placebo |
| MWN109 M | Experimental | MWN109 Cohort M consists of 3 dose groups. In all dose groups, healthy volunteers are randomized to receive subcutaneous injections of MWN109 or placebo with weekly titration dosing for a total of 3 administrations. Receives: Drug: MWN109; 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 43
Secondary outcomes (12)
Maximum Concentration (Cmax)
Cmax of MWN109.
Measured: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109.
Measured: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109.
Measured: From Day 1 to Day 29
Elimination Half-Life (t1/2)
t1/2 of MWN109.
Measured: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN109.
Measured: From Day 1 to Day 43
Steady State Minimum Concentration (Cmin,ss)
Cmin,ss of MWN109.
Measured: From Day 1 to Day 43
Steady State Concentration (Cav,ss)
Cav,ss of MWN109.
Measured: From Day 1 to Day 43
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN109.
Measured: From Day 1 to Day 43
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN109.
Measured: From Day 1 to Day 43
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
AUC0-τ,ss of MWN109.
Measured: From Day 1 to Day 43
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN109.
Measured: From Day 1 to Day 43
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 start18 Dec 2024
- Primary completion20 Jul 2025
- Study completion20 Jul 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
- 48 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
- NCT07787624
- Sponsor's protocol ID
- MWN109-Ia
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1a Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Dose Escalation of MWN109 Injection in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT07787624
- Acronym / sponsor ID
- MWN109-Ia
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Jul 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, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials.
The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen.
Approximately 58 volunteers will 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 S | Experimental | Drug: MWN109, Drug: PlaceboMWN109 Cohort S consists of 4 dose groups. Healthy volunteers in all dose groups were randomly assigned to receive a single subcutaneous dose of MWN109 or placebo. |
| MWN109 M | Experimental | Drug: MWN109, Drug: PlaceboMWN109 Cohort M consists of 3 dose groups. In all dose groups, healthy volunteers are randomized to receive subcutaneous injections of MWN109 or placebo with weekly titration dosing for a total of 3 administrations. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3.
- Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 19.0 to 28.0 kg/m^2 (inclusive).
- From the time of signing the informed consent form (ICF) until 3 months after the last dose, participants must have no plans to become pregnant or to father a child, must agree to use effective contraceptive measures to prevent pregnancy or causing a partner to become pregnant, and must have no plans to donate sperm or eggs.
Key exclusion criteria (8 listed)
- History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 Injection) or severe atopic allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (allergy to two or more foods or drugs) (by inquiry).
- History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury or other high-risk factors that may lead to pancreatitis, or serum amylase > 1.5 × upper limit of normal (ULN) at screening (by inquiry and examination).
- Family history or history of medullary thyroid C-cell tumor/carcinoma; history of thyroid dysfunction or abnormal thyroid hormone levels (by inquiry).
- History or presence at screening of digestive system diseases that may increase the risk to volunteers, such as pancreatitis, abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction, etc.), or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months) (by inquiry).
- History of infectious diseases (which, in the investigator's assessment, may significantly affect the safety evaluation of volunteers) or severe trauma within 4 weeks before screening, or major surgery within 3 months before screening (by inquiry and examination).
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 |
|---|---|---|
| MWN109S1, S2 S3, S4; administered subcutaneously (SC) | Drug | MWN109 S |
| MWN109M1, M2, M3; administered SC | Drug | MWN109 M |
| Placeboadministered SC | Drug | MWN109 M, MWN109 S |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From Day 1 to Day 43
The incidence of adverse events (AEs) and serious adverse events (SAEs).
12 secondary outcomes
Maximum Concentration (Cmax)
Time frame: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: From Day 1 to Day 29
Elimination Half-Life (t1/2)
Time frame: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Time frame: From Day 1 to Day 43
Steady State Minimum Concentration (Cmin,ss)
Time frame: From Day 1 to Day 43
Steady State Concentration (Cav,ss)
Time frame: From Day 1 to Day 43
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame: From Day 1 to Day 43
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame: From Day 1 to Day 43
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame: From Day 1 to Day 43
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame: From Day 1 to Day 43
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 28 Oct 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 MWN109 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 28 Oct 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 43). 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 28 Oct 2026.