A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects

Healthy Volunteers Clinical Trial

Official title: A Phase 1, Open-label Pharmacokinetic Study of Intravenous NTM-001 (A Novel Formulation of Ketorolac Tromethamine Applied by Continuous Intravenous Infusion From A Pre-Mixed Bag) in Healthy Chinese Subjects

Status Completed

Clinical Trial Summary

This will be a single center, open-label phase 1 study in healthy Chinese subjects. A total of up to 16 subjects may be enrolled to achieve a total target of 12 evaluable subjects. A full dose for NTM-001 will be defined as a 12.5 mg IV Loading Dose + 24-hour IV infusion (3.5 mg/hour).

Clinical Trial Description

This will be a single center, open-label phase 1 study in healthy Chinese subjects. A total of up to 16 subjects may be enrolled to achieve a total target of 12 evaluable subjects.

Subjects will remain in-house for the entire study. All subjects will be discharged at End-of-Study (EOS) on Day 5.

A full dose for NTM-001 will be defined as a 12.5 mg IV Loading Dose + 24-hour IV infusion (3.5 mg/hour).

Subjects who withdraw or are withdrawn from the study will not be replaced since attrition is considered.

Blood will be collected for PK analysis. Safety assessments will include the following:

adverse events (AEs), vital sign measurements, physical examinations, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations. infusion site reactions will be recorded as AEs. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05382546
• Study type: Interventional
• Source: Nuance Pharma (shanghai) Co., Ltd
• Status: Completed
• Phase: Phase 1
• Start date: May 23, 2022
• Completion date: March 2, 2023