NCT06310746View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

April 23, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2025

Conditions
IPF
Interventions
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).

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).

Trial Locations (1)

Unknown

First Hospital of Jilin University, Changchun

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

NCT06310746 - 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 | Biotech Hunter | Biotech Hunter