NCT06716151

A Study to Evaluate HB0034 in Healthy Chinese Adult Participants

A Phase I, Randomized, Double-blind, Placebo-controlled, Single/mulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.

Detailed description

This study consisted of a single-dose escalation study and a multi-dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of HB0034 in Chinese healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HB0034	Recombinant Humanized Anti-IL-36R Monoclonal antibody
DRUG	HB0034 matching placebo	HB0034 matching Palcebo

Timeline

• Start date: 2024-12-06
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2024-12-04
• Last updated: 2025-01-20

Locations

1 site across 1 country: China