NCT06999083

A Study to Evaluate Single-dose of HB0043 in Healthy Adult Participants

A Phase Ia, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0043 in Healthy Adult Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the safety and tolerability of HB0043 in healthy subjects following single-dose.

Detailed description

This is a single-dose escalation study of HB0043 to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0043.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HB0043	HB0043 Drug Product
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-06-03
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: New Zealand