RecruitingPhase 1Phase 2NCT06929299

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)

Sponsor

Jiangsu BioJeTay Biotechnology Co., Ltd.

Enrollment

56 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Immune Thrombocytopenia (ITP)

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called STSA-1301 subcutaneous injection for people with primary immune thrombocytopenia (itp). The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTSA-1301 subcutaneous injection

Subjects will receive the STSA-1301 on the dates specified in the protocol

DRUGPlacebo

Subjects will receive the placebo on the dates specified in the protocol

Locations(7)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Xi'an Central Hospital

Xi’an, Shanxi, China

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06929299

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