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

NCT05382546 | Completed Phase 1 FDA Drug

• 1 other identifier: NTM-001-AHC001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Cmax of NTM-001

  Maximum observed plasma concentration (Cmax).

  0 to 96 hours

• AUC0-t of NTM-001

  Area under the plasma concentration-versus-time curve from time 0 to the last collection time after drug administration with a concentration equal to or greater than the lower limit of quantification (AUC0-t).

  0 to 96 hours

• AUC0-∞ of NTM-001

  Area under the plasma concentration-versus-time curve from time 0 extrapolated to infinity after drug administration (AUC0-∞).

  0 to 96 hours

• Tmax of NTM-001

  Time to maximum observed plasma concentration (Tmax).

  0 to 96 hours

• t1/2 of NTM-001

  Apparent terminal elimination half-life (t1/2).

  0 to 96 hours

Study Arms (1)

NTM-001 Treatment Arm

EXPERIMENTAL

NTM-001 loading dose of 12.5 mg administered over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mg/h for 24h, by a pre-programmed infusion pump.

Drug: Ketorolac Tromethamine

Interventions

Ketorolac Tromethamine DRUG

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.

Also known as: NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)

NTM-001 Treatment Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18 to 45 years, inclusive at Screening.
• Subject has a body mass index (BMI) between 19.0 and 24.0 kg/m2 at Screening and Baseline.
• Subject has a body weight ≥50 kg at Screening and Baseline.
• Subject is in good health, as determined by the Investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs and clinical laboratory tests at Screening and Baseline.
• Subject has normal renal function (CrCl ≥ 90 mL/min) as determined by Cockcroft Gault formula at Screening and Baseline.
• Negative blood pregnancy test at Screening and negative urine test at Baseline for women of childbearing potential (WOCBP). For the purposes of this study, WOCBP is defined as: "All female subjects after puberty unless they are postmenopausal for at least 24 months, are surgically sterile for at least 6 months, or are sexually inactive for at least 6 weeks prior to first dose and throughout the study".
• Subject is able to communicate well with the Investigator and is willing to comply with the requirements of the entire study.
• Subject provides a written informed consent prior to the performance of any study procedure.

You may not qualify if:

• 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:
• Known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or HIV antibody positive.
• Hepatitis B virus (HBV) surface antigen positive or Hepatitis C virus (HCV) antibody positive.
• Active tuberculosis (history of exposure or history of positive tuberculin test, plus, presence of clinical symptoms, physical or radiographic findings). If the Investigator suspects a potential risk history for tuberculosis, the physician may use the Quanteferon® test to omit the risk.
• 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.

Sponsors & Collaborators

• Nuance Pharma (shanghai) Co., Ltd: lead

Study Sites (1)

HUK Phase 1 clinical trials center

Hong Kong, Hong Kong, 999077, China

Location

MeSH Terms

Interventions

Ketorolac Tromethamine

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bernard Cheung, Doctor

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 19, 2022
• Study Start: May 23, 2022
• Primary Completion: July 5, 2022
• Study Completion: March 2, 2023
• Last Updated: March 31, 2023

Record last verified: 2022-06

Locations

CN (1)