Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

Trial participants with a history of or currently having any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematological, immunological, psychiatric and metabolic disorders, or any other diseases that may interfere with the study results, or participants with clinically significant allergic reactions or allergic constitution, angioedema, interstitial pneumonitis or acute respiratory distress syndrome;
Participants with abnormal vital signs (systolic blood pressure \< 90 mmHg or \> 140 mmHg, diastolic blood pressure \< 50 mmHg or \> 90 mmHg; heart rate \< 50 bpm or \> 100 bpm) or clinically significant abnormalities in physical examination, ECG and laboratory tests (participant to the judgment of clinicians), and those whose LVEF is beyond the normal range as shown by echocardiography; Adult males with a left ventricular ejection fraction (LVEF) outside the normal reference range of 52% to 72%, as defined by the American Society of Echocardiography (ASE), will be excluded;
QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 450 msec.
Participants with poor venous access;
Participants with a history of allergy to the investigational product (pertuzumab or any of its excipients), or, significant allergy to food, or other substances;
Participants treated with anti-HER2 therapy or any antibody or other protein drug targeting the HER2 receptor;
Participants who have taken any prescription or OTC drugs, including any herbal, and/or nutritional supplements (e.g. vitamins, mineral supplements or other health products) within 14 days before screening;
Use of any monoclonal antibody within 3 months or 5 half-lives (whichever is longer) before administration;
Use of investigational drugs within 30 days or 5 half-lives (whichever is longer) or discontinuation of monoclonal antibodies with unknown half-life within 6 months; prior to scheduled administration of the investigational drugs on Day 1 of this study.

Comparative Study of QL1209 and Perjeta® in Healthy Male Participants

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

QL1209

US-Perjeta®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

QL1209

US-Perjeta®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record