NCT06148389

The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single-ascending Dose, Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics, and Immunogenicity of STSA-1301 Subcutaneous Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, single-ascending dose, phase Ia study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection in healthy subjects.

Conditions

• Primary Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	STSA-1301 subcutaneous injection	Subjects will receive the administration dose on Day 0 following protocol requirements.
DRUG	Placebo	Subjects will receive the administration dose on Day 0 following protocol requirements.

Timeline

• Start date: 2023-11-16
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2023-11-28
• Last updated: 2024-08-12

Locations

1 site across 1 country: China