A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects

The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.

This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product.

Study Overview

• Status: Completed
• Conditions: IPF
• Intervention / Treatment: Drug: GARP/TGF-β1 monoclonal antibody; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Fully informed about the nature, significance, potential inconveniences, and associated risks of the study prior to enrollment. Comprehend the study's procedures and methodology, agree to follow the clinical study protocol, and give voluntary written informed consent;
2. 18-55 years old, including the boundary value, male or female;
3. Body weight: 45-85 kg for females and 50-85 kg for males, including the boundary value; body mass index (BMI): 18.0-28.0 kg/m2 , including the boundary value, (BMI = body weight (kg)/body height2 (m2));
4. Subjects, including males, must have no childbearing plan and take effective contraceptive measures from the time of informed consent to 6 months after the administration of the study drug.
5. Physical examinations and vital signs should be normal or abnormal without clinical significance.

Exclusion Criteria:

1. Any clinically significant laboratory test abnormalities or, within 12 months before screening, any other clinically significant clinical findings indicative of diseases, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular conditions;
2. Donation/loss of ≥ 450 mL of blood or receipt of blood transfusion or use of blood products within 3 months prior to screening, or planning to donate blood during the study or within 1 month after the end of the study;
3. Patients with severe trauma or major surgery within 3 months before screening, or planning to undergo surgery during the study;
4. Patients who smoke more than 5 cigarettes per day in the 3 months before screening;
5. History of drug abuse or addiction or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg).
Experimental: HLX6018	Drug: GARP/TGF-β1 monoclonal antibody; It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)	Safety evaluation	0 to Day 99

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf	Area under the serum concentration-time curve	0 to Day 99
Cmax	Peak concentration	0 to Day 99
Tmax	Time to reach peak concentration	0 to Day 99
T1/2	Terminal elimination half-life	0 to Day 99
CL	Clearance	0 to Day 99
λz	Terminal elimination rate constant	0 to Day 99

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2024
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: HLX6018-FIH101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No