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The Safety and Tolerability of STSA-1005 Following Intravenous Infusion in Healthy Subjects

NCT05085197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-04-18

No results posted yet for this study

Summary

This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different doses and dose-matched placebo were administered under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

STSA-1005 injection

Intravenous injection

DRUG

Placebo

Intravenous injection

DRUG

STSA-1005 injection

Intravenous injection

DRUG

Placebo

Intravenous injection

DRUG

STSA-1005 injection

Intravenous injection

DRUG

Placebo

Intravenous injection

DRUG

STSA-1005 injection

Intravenous injection

DRUG

Placebo

Intravenous injection

Sponsors & Collaborators

  • Staidson Biopharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2022-04-05
Completion
2022-04-05
FDA Drug
Yes

Countries

  • United States

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 NCT05085197 on ClinicalTrials.gov