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

NCT06148389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Ronghua Jin, Doctor · Beijing Ditan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2024-04-03
Completion
2024-04-03

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 NCT06148389 on ClinicalTrials.gov