NCT06929299

A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Jiangsu BioJeTay Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic/pharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous injection in healthy subjects and patients with ITP, and to further explore the initial efficacy of STSA-1301 subcutaneous injection in patients with ITP

Conditions

• Primary Immune Thrombocytopenia (ITP)

Interventions

Type	Name	Description
DRUG	STSA-1301 subcutaneous injection	Subjects will receive the STSA-1301 on the dates specified in the protocol
DRUG	Placebo	Subjects will receive the placebo on the dates specified in the protocol

Timeline

• Start date: 2025-05-12
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-04-16
• Last updated: 2026-01-16

Locations

7 sites across 1 country: China