Metabolic Dysfunction-Associated Steatohepatitis(MASH)Phase 1NCT07331545
Safety, Tolerability, PK, PD, and Immunogenicity of QL2401 in Healthy Chinese Adults
A Phase 1 study testing QL2401 in people with Metabolic Dysfunction-Associated Steatohepatitis(MASH), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple ascending subcutaneous doses in healthy Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis(MASH)
- What is being tested?
- QL2401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to 24 Jun 2026
- 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
- Healthy male and female participants, aged 18 to 45 years at the time of screening.
- Body weight of males should be ≥50.0kg and body weight of females should be≥45.0kg, BMI 18.5-32.5 kg/m² (Including boundary values)at the time of screening.
- During the screening and baseline periods, participants with normal laboratory tests, vital sign measurements, physical examination results, 12-lead electrocardiogram, and abdominal B-ultrasound results, or those with abnormalities judged by the investigators as having no clinical significance (MAD section: those with clinically significant lipid indicators and abdominal B-ultrasound results but meeting the following criteria can be included: TC< 7.2mmol/L, LDL-C< 4.9mmol/L, TG< 4.52mmol/L; Abdominal B-ultrasound indicates mild or moderate fatty liver).
- Participants voluntarily signed the informed consent form before the trial.
- Willing to use contraception and comply with study procedures.
Who cannot join
- Serious, progressive, and uncontrolled diseases, including but not limited to the cardiovascular system, endocrine and metabolic system, immune system, urinary system, digestive system, respiratory system, blood system, gynecological system, nervous system, mental system, and musculoskeletal system, and the researcher determines that the participant is not suitable for this trial;
- Serious or chronic recurrent gastrointestinal diseases (such as chronic diarrhea, active ulcer, reflux esophagitis), or screening before 12 weeks underwent gastrointestinal surgery;
- History of acute or chronic pancreatitis, history of symptomatic gallbladder, pancreas injury can lead to high risk factors of acute pancreatitis, or screening blood amylase > 1.5 x upper limit of normal range (ULN);
- Type 1 diabetes, type 2 diabetes or other types of diabetes;
- Abnormal liver, renal, or cardiac function
- Positive for hepatitis B, C, HIV, or syphilis
Show all 10Show fewer
- Pregnant or breastfeeding women
- History of drug or alcohol abuse
- Use of prescription drugs within 2 weeks prior to dosing
- According to the researcher's judgment, it may increase the risks related to the research, may interfere with the interpretation of the research results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of QL2401 in Healthy Chinese Adult Participants
This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple ascending subcutaneous doses in healthy Chinese adults. The study consists of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Participants will be randomly assigned to receive either QL2401 or placebo. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of PK parameters in SAD \& MAD; exploratory objectives include assessment of PD biomarkers and immunogenicity.
- Being tested
- QL2401, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL2401Drug
QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401.
PlaceboDrug
Matching placebo administered via subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| QL2401 | Experimental | Not described Receives: Drug: QL2401 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Safety and tolerability as assessed by the incidence and severity.
Measured: From baseline up to 29 days after last dose (SAD) or 57 days after last dose(MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start21 Jan 2026
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatohepatitis(MASH)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331545
- Sponsor's protocol ID
- QL2401-101
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of QL2401 in Healthy Chinese Adult Participants
- ClinicalTrials.gov ID
- NCT07331545
- Acronym / sponsor ID
- QL2401-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 12 Jan 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 first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple ascending subcutaneous doses in healthy Chinese adults. The study consists of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). Participants will be randomly assigned to receive either QL2401 or placebo. The primary objective is to assess safety and tolerability. Secondary objectives include evaluation of PK parameters in SAD \& MAD; exploratory objectives include assessment of PD biomarkers and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL2401 | Experimental | Drug: QL2401 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female participants, aged 18 to 45 years at the time of screening.
- Body weight of males should be ≥50.0kg and body weight of females should be≥45.0kg, BMI 18.5-32.5 kg/m² (Including boundary values)at the time of screening.
- During the screening and baseline periods, participants with normal laboratory tests, vital sign measurements, physical examination results, 12-lead electrocardiogram, and abdominal B-ultrasound results, or those with abnormalities judged by the investigators as having no clinical significance (MAD section: those with clinically significant lipid indicators and abdominal B-ultrasound results but meeting the following criteria can be included: TC< 7.2mmol/L, LDL-C< 4.9mmol/L, TG< 4.52mmol/L; Abdominal B-ultrasound indicates mild or moderate fatty liver).
- Participants voluntarily signed the informed consent form before the trial.
- Willing to use contraception and comply with study procedures.
Key exclusion criteria (10 listed)
- Serious, progressive, and uncontrolled diseases, including but not limited to the cardiovascular system, endocrine and metabolic system, immune system, urinary system, digestive system, respiratory system, blood system, gynecological system, nervous system, mental system, and musculoskeletal system, and the researcher determines that the participant is not suitable for this trial;
- Serious or chronic recurrent gastrointestinal diseases (such as chronic diarrhea, active ulcer, reflux esophagitis), or screening before 12 weeks underwent gastrointestinal surgery;
- History of acute or chronic pancreatitis, history of symptomatic gallbladder, pancreas injury can lead to high risk factors of acute pancreatitis, or screening blood amylase > 1.5 x upper limit of normal range (ULN);
- Type 1 diabetes, type 2 diabetes or other types of diabetes;
- Abnormal liver, renal, or cardiac function
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 |
|---|---|---|
| QL2401QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401. | Drug | QL2401 |
| PlaceboMatching placebo administered via subcutaneous injection. | Drug | Placebo |
Primary outcome
Incidence and severity of adverse events
Time frame: From baseline up to 29 days after last dose (SAD) or 57 days after last dose(MAD)
Safety and tolerability as assessed by the incidence and severity.
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 2 Sep 2026.
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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 QL2401 in people with Metabolic Dysfunction-Associated Steatohepatitis(MASH), run by Qilu Pharmaceutical 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 5 inclusion and 10 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 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. 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?
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 and severity of adverse events (time frame: From baseline up to 29 days after last dose (SAD) or 57 days after last dose(MAD)). 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.