The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People

NCT03255993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-11-15

No results posted yet for this study

Summary

This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing

Conditions

Interventions

DRUG

SPH3127 50mg

SPH3127 50mg

DRUG

SPH3127 100mg

SPH3127 100mg

DRUG

Placebo matching to SPH3127 50mg

Placebo matching to SPH3127 50mg

DRUG

Placebo matching to SPH3127 100mg

Placebo matching to SPH3127 100mg

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2018-09-20
Completion
2018-09-20

Countries

  • China

Study Locations

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Entities

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 NCT03255993 on ClinicalTrials.gov