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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects

NCT04453618 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-07-01

No results posted yet for this study

Summary

A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food Effect) of SYHA1402 in Healthy Subjects.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

FE-SYHA1402 100mg

in either a fasted state or with a meal

DRUG

SYHA1402-25mg

SYHA1402 25mg, oral tablets

DRUG

Placebo-25mg

Matching placebo tablets

DRUG

SYHA1402-50mg

SYHA1402 50mg, oral tablets

DRUG

Placebo-50mg

Matching placebo tablets

DRUG

SYHA1402-150mg

SYHA1402 150mg, oral tablets

DRUG

Placebo-150mg

Matching placebo tablets

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

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
2020-08-31
Primary Completion
2020-12-31
Completion
2020-12-31

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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 NCT04453618 on ClinicalTrials.gov