Investigating the safety and effects of HLX6018 in healthy individuals

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

This study is testing a new monoclonal antibody called HLX6018 in healthy people to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Henlius Biotech (Industry-sponsored)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06310746 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, pharmacokinetics, and immunogenicity of HLX6018, a monoclonal antibody, through a single intravenous dose in healthy subjects. The study employs a randomized, double-blind, placebo-controlled design with multiple dose escalation groups, enrolling 8-10 participants in each group. The trial is designed as a first-in-human study, building on preliminary efficacy and safety data from earlier experiments.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18-55 who meet specific weight and BMI criteria.

Not a fit: Patients with significant laboratory abnormalities or those with a history of clinically significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for patients with idiopathic pulmonary fibrosis (IPF).

How similar studies have performed: While this is a first-in-human study, similar monoclonal antibody approaches have shown promise in other clinical settings.

Eligibility criteria

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);

Where this trial is running

Changchun, Jilin

• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yanhua Ding

Conditions IPF