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

NCT05382546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-03-31

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Nuance Pharma (shanghai) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Bernard Cheung, Doctor · Queen Mary Hospital, Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2022-07-05
Completion
2023-03-02
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT05382546 on ClinicalTrials.gov