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Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Healthy Elderly Subjects

NCT04197661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-12-17

No results posted yet for this study

Summary

It is a single-center, open-label, dose-finding, Phase I clinical study evaluating the pharmacokinetics, pharmacodynamics, and safety characteristics of HSK3486 in healthy elderly subjects.

Conditions

  • Healthy Elderly Subjects

Interventions

DRUG

HSK3486

Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

DRUG

HSK3486

Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

DRUG

HSK3486

Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

DRUG

HSK3486

Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, PhD · Phase I Clinical Trial Laboratory，The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-25
Primary Completion
2020-01-22
Completion
2020-05-22

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 NCT04197661 on ClinicalTrials.gov