cancer
Conditions
Interventions
HM001 treatment group:Dissolve 1mg of HM001 freeze-dried powder in 1ml of physiological saline to prepare a 1mg/mL administration solution. Administer by intramuscular injection, twice daily (once eve
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.For patients with moderate to severe cancer pain (average vas score = 4), the current clinical analgesic drugs fail to control the pain adequately, significantly affecting the patient's quality of life; 2.Aged = 18 years, gender not limited; 3.Participants with tumors confirmed by pathological histology or cytology; 4.18 45 kg; 5.Expected survival = 3 months; 6.Participants willing not to use any other analgesics outside the study regulations during the entire study period; 7.Ecog performance status score of 0-3; 8.Adequate organ and bone marrow functions; Patients who can understand the pain intensity assessment method and sign the informed consent form. Evaluate the pharmacokinetic characteristics of hm001.
Exclusion criteria
Exclusion criteria: 1.Patients who are known to be allergic to any active ingredient or excipient of the study drug, or who have a history of allergy to other opioids and their related components; patients who have undergone neurosurgery, liver surgery, kidney surgery, or heart surgery; 2.Patients with active peptic ulcers, or those who have had gastrointestinal bleeding or perforation in the past 3 months (except for bleeding caused by the disease itself of colorectal cancer); 3.Patients with mental or neurological disorders and who cannot express their wishes correctly; 4.Pregnant or lactating women; 5.Study participants who plan to receive radiotherapy, surgical treatment, or start new systemic anti-tumor drug therapy during the study; 6.Study participants who currently have a history of alcohol abuse, drug abuse, or/and opioid abuse; 7.Study participants who have serious contraindications to opioids; 8.Patiens who electrocardiogram during the screening period shows second or third-degree heart block, or prolonged qtc interval, or any other active arrhythmia or cardiac abnormality that may pose a clinical risk; 9.Patients who have used any investigational drugs within the past 30 days before screening, or who plan to receive other investigational drugs during the study except for tetrodotoxin; 10.Patiens who have participated in other clinical trials in the past 3 months; 11.Patients deemed unsuitable for inclusion by the researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of excellent pain control;time to peak;Electrocardiograph data; | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in VAS score;vital signs;Laboratory indicators such as blood routine examination;adverse event;The area under the blood concentration-time curve;Peak concentration;elimination half-life;Drug apparent clearance rate;apparent volume of distribution;Mean Residue Time; | — |
Countries
China
Contacts
Public ContactZhang Zhi,Wang Likui,Liu Xuesheng
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed