Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Chinese Subjects

Keywords

EtripamilParoxysmal supraventricular tachycardiaTachycardiaTachycardia, Supraventricular

Outcome Measures

Primary Outcomes (2)

Cmax of Etripamil after single dosing
To measure Cmax of Etripamil after single dosing
Day -1 to Day 11
Cmax of MSP-2030 after single dosing
To measure Cmax of MSP-2030 after single dosing
Day -1 to Day 11

Secondary Outcomes (7)

PR interval after single dosing
Day -1 to Day 11
Blood pressure after single dosing
Day -1 to Day 11
Heart rate after single dosing
Day -1 to Day 11
Subject incidence of Adverse Event (AE)
Day -1 to Day 11
Subject electrocardiogram outcomes
Day -1 to Day 11
+2 more secondary outcomes

Study Arms (2)

Etripamil Nasal Spray 70mg

EXPERIMENTAL

Etripamil Nasal Spray 70mg single dose

Drug: Etripamil Nasal Spray 70mg

Etripamil Placebo Nasal Spray 70mg

PLACEBO COMPARATOR

Etripamil Placebo Nasal Spray 70mg single dose

Drug: Placebo

Interventions

Etripamil Nasal Spray 70mgDrug

Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Etripamil Nasal Spray 70mg

PlaceboDrug

Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Subjects who meet all the following criteria at screening may be included in the study:
Ethnically Chinese men or women, 18 to 45 years of age (inclusive).

Sponsors & Collaborators

Milestone Pharmaceuticals Inc.
Othercollaborator
Corxel Pharmaceuticals
Industrylead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

MeSH Terms

Conditions

Tachycardia, VentricularTachycardiaTachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Jing ZHANG
Huashan Hospital
PRINCIPAL INVESTIGATOR
Yuewen XI
Huashan Hospital
PRINCIPAL INVESTIGATOR
Lihang QI
Corxel Pharmaceuticals
STUDY DIRECTOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Masking Details: JX02001 is a double blind phase 1 study.
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2022

First Posted

August 23, 2022

Study Start

March 7, 2023

You may not qualify if:

Non-smoker or ex-smoker for \>6 months.
From the time they sign the informed consent to 90 days (male subject within 30 days) after dosing, subjects have no plans to have children and voluntarily use effective contraception
Any of the following will exclude subjects from the study:
Have a history of, or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal disease; thyroid disease; neurologic or psychiatric disease; or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
A history of atrioventricular (AV) block, (1st, 2nd or 3rd degree), myocardial infarction (MI) or angina, non-sustained or sustained ventricular tachycardia (VT), torsade de pointes, family history of sudden death or prolonged QT interval, vaso-vagal syncope, sick sinus syndrome, supraventricular tachycardia, atrial flutter, atrial fibrillation (AFib), stroke, transient ischemic attack (TIA), unexplained syncope, congestive heart failure (CHF).
Acute upper respiratory tract infection within 14 days prior to dosing.
Any abnormality of the nasal passage.
Unable to tolerate IN administration.
Known sensitivity to verapamil or other drugs or foods.
Clinically significant abnormal values for clinical laboratory tests at screening as deemed appropriate by the investigator.
Serum potassium \<3.5mmol/L or serum magnesium \<0.75mmol/L or serum calcium \<2.11mmol/L.
Systolic blood pressure (SBP) \<100 or \>140 mmHg, diastolic blood pressure (DBP) \<55 or \>90 mmHg, HR \<65 or \>95 bpm.
QTcF \>440 msec, flat or biphasic T waves, QRS \>105 ms, evidence of a prior MI, pathologic U waves or U waves that interfere with the QT measurement, AV block or left anterior hemiblock (LAHB) or left posterior hemiblock (LPHB) or right bundle branch block (RBBB) or left bundle branch block (LBBB), pre-excitation syndrome.
Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as deemed appropriate by the Investigator.
Have a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; have a history of treponema pallidum antibody positive, or tests positive for treponema pallidum; have a history of hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) positive, or other clinically active liver disease, or tested positive for HBsAg or HCVAb at screening.
+8 more criteria

A Study of Etripamil in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Etripamil Nasal Spray 70mg

Etripamil Placebo Nasal Spray 70mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (2)

Etripamil Nasal Spray 70mg

Etripamil Placebo Nasal Spray 70mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations