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

IPF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310746
• Other study ID #: HLX6018-FIH101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 23, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Shanghai Henlius Biotech
• Contact: Yanhua Ding
• Email: dingyanhua2003[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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);

Related Conditions & MeSH terms

• IPF

Intervention

Drug:
• GARP/TGF-ß1 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).
• 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).

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)	Safety evaluation	0 to Day 99
Secondary	AUC0-inf	Area under the serum concentration-time curve	0 to Day 99
Secondary	Cmax	Peak concentration	0 to Day 99
Secondary	Tmax	Time to reach peak concentration	0 to Day 99
Secondary	T1/2	Terminal elimination half-life	0 to Day 99
Secondary	CL	Clearance	0 to Day 99
Secondary	?z	Terminal elimination rate constant	0 to Day 99