NCT06026748

A Phase I Study of XJ103 in Chinese Healthy Subjects

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ103 in Chinese Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Starmab biologics（Shanghai）Co,.ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects will be assigned to one of four different dosage cohorts. Subjects in each cohort will randomly be given experimental drug or a placebo.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
DRUG	XJ103 Injection	XJ103 is a humanized monoclonal antibody.
DRUG	Placebo	Placebo contains only excipients.

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-12-24
• Completion: 2025-03-06
• First posted: 2023-09-07
• Last updated: 2024-03-27

Locations

1 site across 1 country: China