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

NCT05702983 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Martin K Kankam, Doctor · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
57 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-04-11
Completion
2023-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05702983 on ClinicalTrials.gov