NCT05429385

Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Study to Evaluate Safety and Pharmacokinetics of HLX70 in Healthy Adult Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A single-center, randomized, double-blind, placebo-controlled, dose escalation, phase I clinical study to evaluate safety and pharmacokinetics of HLX70 in healthy adult volunteers

Detailed description

A randomized, double-blind, single-dose by intravenous administration, placebo-controlled, dose escalation, first-in-human study is proposed to evaluate the safety, PK, and immunogenicity of HLX70 in healthy subjects. We plan to enroll 8 subjects in each of the 3 dose cohorts at 3 mg/kg, 10 mg/kg, and 30 mg/kg, of which 2 receive intravenous injections of placebo and 6 receive intravenous injections of the investigational product (IP). A total of 24 subjects will be enrolled.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	HLX70	Single-dose, intravenous infusion
DRUG	Placebo	Single-dose, intravenous infusion

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-09-06
• Completion: 2021-09-18
• First posted: 2022-06-23
• Last updated: 2022-06-23

Regulatory

• FDA-regulated drug study