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A Safety Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

NCT04747964 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-09-19

No results posted yet for this study

Summary

This study will assess the pharmacokinetics and pharmacodynamics of STSP-0601 at six dose levels. The results will help identify the most optimal doses to treat bleedings in hemophilia patients with inhibitors.

Conditions

Interventions

DRUG

STSP-0601 for Injection

Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements

DRUG

STSP-0601 for Injection

Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements

DRUG

STSP-0601 for Injection

Subjects will receive one single low-intermediate dose of STSP-0601 for Injection following protocol requirements

DRUG

STSP-0601 for Injection

Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements

DRUG

STSP-0601 for Injection

Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements

DRUG

STSP-0601 for Injection

Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements

Sponsors & Collaborators

  • Staidson (Beijing) Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lei Zhang · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-04-19
Completion
2021-04-19

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT04747964 on ClinicalTrials.gov