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

NCT06929299 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu BioJeTay Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lei Zhang, M.D. · Hospital of Hematology, Chinese Academy of Medical Sciences

  • Yi Fang, Ph.D · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929299 on ClinicalTrials.gov