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Phase 1 Study to Evaluate Safety and Pharmacokinetics of FZJ-003 in Healthy Volunteers

NCT04715529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-03-12

No results posted yet for this study

Summary

A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and fasting/postprandial pharmacokinetics of FZJ-003, an oral Janus kinase1 (JAK1) inhibitor.

Conditions

  • Healthy Volunteers

Interventions

DRUG

FZJ-003

Subjects will receive FZJ-003 oral capsules in a dose escalation format.

DRUG

Placebo

Subjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format .

Sponsors & Collaborators

  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-07-13
Completion
2022-07-13

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04715529 on ClinicalTrials.gov