F573 Ia Clinical Trial

Phase 1

Completed

• Conditions: Tolerance; Pharmacokinetic
• Interventions: Other: Placebo; Drug: F573

• Registration Number: NCT04820049
• Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Brief Summary

Tolerance and PK study of F573

Detailed Description

The tolerance and PK study of single dose and multi dose F573.

Study Timeline

• Study First Submitted: 2021-02-03
• Study Start: 2021-02-08
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Primary Completion: 2022-08-02
• Study Completion: 2022-11-06
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	-
F573 group	F573	-

Primary Outcome Measures

Name	Time	Method
MTD of F573 in health people	up to 7 days
AUC of F573 in health people	up to 7 days
Cmax of F573 in health people	up to 7 days
Tmax of F573 in health people	up to 7 days
t1/2 of F573 in health people	up to 7 days

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	8 days

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China