Safety, Tolerability, PK, PD, and Immunogenicity of QL2401 in Healthy Chinese Adults

NCT ID: NCT07331545

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief 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. 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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis(MASH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

QL2401

Group Type: EXPERIMENTAL

QL2401

Intervention Type: DRUG

QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo administered via subcutaneous injection.

Interventions

QL2401

QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401.

Intervention Type: DRUG

Placebo

Matching placebo administered via subcutaneous injection.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dandan Guo, MD

Role: CONTACT

dandan1.guo@qilu-pharma.com

+86-0531-5582-1177

Other Identifiers

QL2401-101

Identifier Type: -

Identifier Source: org_study_id