NCT05382546

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nuance Pharma (shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

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 Subjects who withdraw or are withdrawn from the study will not be replaced since attrition is considered.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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (\~0.9% NaCl) adjusted to a pH of \~7.4. Contained in a sterile, polyolefin bag filled with 125 mL of NTM-001.

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-07-05
• Completion: 2023-03-02
• First posted: 2022-05-19
• Last updated: 2023-03-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study