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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).
Full 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Subjects who withdraw or are withdrawn from the study will not be replaced since attrition is considered.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.
Enrollment
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Inclusion criteria
Exclusion criteria
Subject has known hypersensitivity to ketorolac or any of the excipients in the Test or Reference formulations
There is evidence in the subject's medical history or in the medical examination or clinical laboratory results of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, hematological or other significant acute or chronic abnormalities which might influence either the safety of the subject, interfere with trial procedures or outcomes, explicitly the absorption, distribution, metabolism or excretion of the active agent under investigation.
Subjects who smoked more than 5 cigarettes per day during the 3 months prior to screening or did not agree to refrain from using any tobacco products during the study period.
Subject has significant acute or chronic infections, including, among others:
Subject has chronic malnutrition or severe hypovolemia.
Subject is pregnant or breastfeeding. Pregnancy status will be confirmed by serum assay for qualitative human chorionic gonadotropin (hCG) at Screening and urine assay at Baseline for females of child-bearing potential.
Subject has a positive test result for amphetamines including methylenedioxymethamphetamine and methamphetamine, barbiturates, benzodiazepines, cocaine, marijuana (THC), opioids including opiates and methadone or alcohol (blood) at Screening or Baseline.
Subject has a history of any drug or alcohol abuse in the past 2 years or alcohol consumption greater than 21 units per week. A unit of alcohol will be equivalent to 1 can of beer, 1 glass of wine, or the equivalent of 1 alcoholic drink. Alcohol consumption is prohibited within 96 hours before entry to the study site on Day -1 and throughout the entire study until discharge.
Subject has donated or lost greater than 50 mL of blood in the 3 months prior to the administration of the first dose of study drug.
Subject has taken or will need taking any prescription or nonprescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks before the start of study treatment until completion of the end of study/early termination visit or 5 half-lives of investigational drug, whichever was longer.
Subject has been administered a live vaccine within 28 days prior to study entry.
Subject has contacted with a confirmed or suspected COVID-19 patient within 14 days prior to screening.
Subject has current or past clinical study participation in the past 3 months or within 5 half-lives of the investigational drug, whichever was greater.
Subject has any medical condition wherein the Investigator determines the subject is not suited for this study, including but not limited to subjects who have conditions that are contraindicated as outlined in the ketorolac product label such as:
Subject is institutionalized.
Subject has any psychiatric condition that would prohibit the understanding or rendering of informed consent or that would limit compliance with study requirements.
Females of childbearing potential refuse to use one of the following acceptable birth control methods:
Male subjects who are apt to procreate refuse to use an acceptable contraceptive regimen during the entire study, and until at least 90 days after the drug administration.
Study site personnel or sponsor's employees are NOT allowed to participate in this study.
Primary purpose
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Interventional model
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16 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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