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

Last updated: June 13, 2024
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Recruiting

Phase

1

Condition

Idiopathic Pulmonary Fibrosis

Treatment

GARP/TGF-β1 monoclonal antibody

Placebo

Clinical Study ID

NCT06310746
HLX6018-FIH101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fully informed about the nature, significance, potential inconveniences, andassociated risks of the study prior to enrollment. Comprehend the study's proceduresand methodology, agree to follow the clinical study protocol, and give voluntarywritten 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 boundaryvalue; 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 effectivecontraceptive measures from the time of informed consent to 6 months after theadministration of the study drug.

  5. Physical examinations and vital signs should be normal or abnormal without clinicalsignificance.

Exclusion

Exclusion Criteria:

  1. Any clinically significant laboratory test abnormalities or, within 12 months beforescreening, any other clinically significant clinical findings indicative ofdiseases, 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 bloodproducts within 3 months prior to screening, or planning to donate blood during thestudy or within 1 month after the end of the study;

  3. Patients with severe trauma or major surgery within 3 months before screening, orplanning 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: 1unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: GARP/TGF-β1 monoclonal antibody
Phase: 1
Study Start date:
April 23, 2024
Estimated Completion Date:
December 30, 2026

Connect with a study center

  • First Hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

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