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A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults

NCT03751969 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-06-02

No results posted yet for this study

Summary

This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous \[14C\]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and provide a reference for reasonable use of this drug.

Conditions

  • Anesthesia
  • Sedation

Interventions

DRUG

HSK3486

The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing \[14C\] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects.

Sponsors & Collaborators

  • Sichuan Haisco Pharmaceutical Group Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2020-11-01
Completion
2020-12-01

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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 NCT03751969 on ClinicalTrials.gov