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A Study of Etripamil in Healthy Subjects

NCT05511870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-04-10

No results posted yet for this study

Summary

The objectives of the study are as below:

Primary:

·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects

Secondary:

* To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
* To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects

Exploratory:

·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects

Conditions

  • Healthy Chinese Subjects

Interventions

DRUG

Etripamil Nasal Spray 70mg

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Milestone Pharmaceuticals Inc.

    collaborator OTHER

  • Corxel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jing ZHANG · Huashan Hospital

  • Yuewen XI · Huashan Hospital

  • Lihang QI · Corxel Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2023-03-26
Completion
2023-03-26
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT05511870 on ClinicalTrials.gov