A Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7249 Injection in H… (NCT06541457) | Clinical Trial Compass
CompletedPhase 1
A Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7249 Injection in Healthy Subjects
China48 participantsStarted 2024-08-15
Plain-language summary
It is a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. The study plans to conduct four to six dose groups of dose 1, dose 2, dose 3, dose4, dose5 (optional), and dose 6(optional). Eight subjects will be enrolled for each dose group, with six administered HRS-7249 injection and two administered placebo. A total of 32 to 48 healthy subjects are planned to be enrolled.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able and willing to provide a written informed consent；
✓. Age ≥ 18 and ≤ 65 years old on the day of signing the informed consent ；
✓. 0.9 mmol/L≤TG≤5.6 mmol/L；
✓. Male or female；
✓. Male subjects weigh ≥ 50 kg and \< 90 kg , female subjects weigh ≥ 45kg and \< 90 kg, and BMI is in the range of 19\~30 kg/m2 ；(including boundary values) Normal or abnormality such as vital signs, physical examination and laboratory examination have no clinical significance；
✓. Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 6 months after the last study drug administration.
Exclusion criteria
✕. Those who suffer from any disease that affects drug absorption, distribution, metabolism, and excretion, or can reduce compliance determined by investigators;
✕. Those who suffer from any clinical diseases such as as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities;
✕. A clinically significant history of drug allergies or atopic allergic diseases (asthma, urticaria, eczematous dermatitis);
✕. Those with a history of malignant diseases;
✕. Those with a history of involving clinical trials of any other drugs or medical devices within the previous 3 months of screening or planned to be conducted during the study period (excluding screening failures), or those who are still within 5 half-lives of the drugs before screening (whichever is longer);
What they're measuring
1
Safety and tolerability: Incidence of subjects with adverse events (AEs)
✕. Those who have experienced severe trauma or surgery within the previous 6 months, or plan to undergo surgery during the trial period; Serious infected individuals within the previous 3 months of screening;
✕. Those who have used any drugs during the screening period or within 2 weeks before the baseline period; or those who are still in 5 half-lives of the drug at the time of screening (whichever is longer);