MedTrace Logo

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants

NCT06673927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-02-10

No results posted yet for this study

Summary

Primary Objective：

1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants
2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants

Secondary objectives:

To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen

Conditions

Interventions

DRUG

YZJ-1139

Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg

DRUG

YZJ-1139

Multiple Dosing ，Each oral dose of 10 mg，20 mg，40 mg or 60 mg

DRUG

Placebo

Placebo administration

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2018-11-21
Completion
2019-03-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06673927 on ClinicalTrials.gov