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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Dysfunction-Associated Steatohepatitis(MASH)
• Intervention / Treatment: Drug: QL2401; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dandan Guo, MD; Phone Number: +86-0531-5582-1177; Email: dandan1.guo@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo administered via subcutaneous injection.
Experimental: QL2401	Drug: QL2401; QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive single or multiple ascending doses of QL2401.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	Safety and tolerability as assessed by the incidence and severity.	From baseline up to 29 days after last dose (SAD) or 57 days after last dose(MAD)

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: QL2401-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No