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Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium

NCT03804749 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-01-15

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, single-dose with three incremental doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for injection in Chinese healthy adults.

Conditions

  • Hand, Foot and Mouth Disease

Interventions

DRUG

suramin sodium

The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。

OTHER

placebo

Placebo is 0.9% sodium chloride injection.

Sponsors & Collaborators

  • Guangdong Kangda Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Principal Investigators

  • First Affiliated Hospital Zhejiang University · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-12-19
Completion
2020-12-19

Countries

  • China

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 NCT03804749 on ClinicalTrials.gov