Healthy volunteers test new MASH drug in early safety trial
NCT ID NCT07331545
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This early-stage study tests the safety and tolerability of a new drug called QL2401 in 70 healthy Chinese adults aged 18 to 45. Participants receive either the drug or a placebo to see how the body handles it. The goal is to gather initial safety data before testing in people with MASH, a liver condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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71 people
The number who actually took part.
- Started
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Jan 2026
- Finished
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Jun 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy male and female participants, aged 18 to 45 years at the time of screening. 2. 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. 3. 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). 4. Participants voluntarily signed the informed consent form before the trial. 5. Willing to use contraception and comply with study procedures. Exclusion Criteria: 1. 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; 2. Serious or chronic recurrent gastrointestinal diseases (such as chronic diarrhea, active ulcer, reflux esophagitis), or screening before 12 weeks underwent gastrointestinal surgery; 3. 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); 4. Type 1 diabetes, type 2 diabetes or other types of diabetes; 5. Abnormal liver, renal, or cardiac function 6. Positive for hepatitis B, C, HIV, or syphilis 7. Pregnant or breastfeeding women 8. History of drug or alcohol abuse 9. Use of prescription drugs within 2 weeks prior to dosing 10. According to the researcher's judgment, it may increase the risks related to the research, may interfere with the interpretation of the research results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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No. 8888 Lvyou Road
Jinan, Shandong, 250000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can cold exposure melt away liver fat?
- Can a weekly shot reverse liver damage from fatty liver disease?
- Can Weight-Loss surgery beat drugs for advanced liver damage?
- Can a single gene therapy injection reverse fatty liver disease?
- Navy beans take on fatty liver: a diet swap put to the test
- Could a tailored diet make a MASH drug work better?