NCT05702983

The Safety and Tolerability of STSA-1002 Following Subcutaneous Injection in Healthy Subjects

An Open-label, Single-ascending Dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 21 Years – 57 Years
• Healthy volunteers: Accepted

Summary

An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects

Conditions

• Antineutrophil Cytoplasmic Antibody Associated Vasculitis

Interventions

Type	Name	Description
DRUG	STSA-1002 subcutaneous injection	Subjects will receive a single low dose on day 1 following protocol requirements.
DRUG	STSA-1002 subcutaneous injection	Subjects will receive a single high dose on day 1 following protocol requirements.

Timeline

• Start date: 2023-01-31
• Primary completion: 2023-04-11
• Completion: 2023-04-24
• First posted: 2023-01-27
• Last updated: 2023-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study