Hyperlipidemias
Conditions
Brief summary
This phase I study in healthy participants aims to assess the pharmacokinetics of midazolam and atorvastatin when administered alone and in combination with HRS-1301, and to assess the safety of HRS-1301 when administered alone and in combination with midazolam or atorvastatin.
Interventions
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label, single-arm, fixed-sequence, pharmacokinetics, safety and tolerability study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be aged ≥ 18 years and ≤ 55 years on the day of signing the informed consent form (ICF); 2. At screening, body mass index (BMI) must be ≥ 19.0 kg/m² and \< 28 kg/m², with body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; 3. Physical examination, vital signs, electrocardiogram (ECG), posteroanterior and lateral chest X-ray/CT, abdominal ultrasound, and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, and thyroid function) were normal or abnormal but of no clinical significance; 4. Female participants must not be pregnant or lactating and must have negative pregnancy test results prior to investigational drug administration; participants must have had no unprotected sexual intercourse within two weeks prior to screening; female participants of childbearing potential and male participants with partners of childbearing potential must agree to comply with the contraception requirements for the duration specified in the protocol and have no plans to donate sperm or eggs; 5. Subjects who understand the study procedures and methods, voluntarily agree to participate in this trial, and provide written informed consent (ICF).
Exclusion criteria
1. Subjects with previous medical history or current diagnosis of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, infectious, immunological, malignant neoplastic, neurological, or psychiatric/metabolic disorders/dysfunctions, or any other disease; 2. Subjects who have gastrointestinal, hepatic, renal, or other known diseases that may affect drug absorption, distribution, metabolism, or excretion, or that may reduce compliance; 3. Subjects who have experienced severe trauma or undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial period; 4. Subjects with a history of specific allergies, or with an allergic constitution, or with known hypersensitivity to any component of the investigational drug; 5. Subjects who have used any medication within 2 weeks prior to screening, or who are still within 5 half-lives of any medication at the time of screening; 6. Subjects who have participated in any other clinical trial of a drug or medical device within 3 months prior to screening, or who are still within 5 half-lives of a prior investigational drug at the time of screening; 7. Subjects who have donated blood ≥ 200 mL or experienced significant blood loss (≥ 400 mL) within 4 weeks prior to screening, or who have received a blood transfusion within 8 weeks prior to screening; 8. Subjects who have received a live (attenuated) vaccine within 4 weeks prior to screening or plan to receive such a vaccine during the trial period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam when administered alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-last) | Up to 18 days. | Plasma pharmacokinetics (PK) parameters of Atorvastatin when administered alone and in combination with HRS-1301 tablets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach maximum observed concentration (Tmax) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. |
| Terminal elimination half-life (t1/2) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. |
| Apparent clearance (CL/F) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam and 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. |
| Apparent volume of distribution (Vz/F) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of Midazolam 1-hydroxymidazolam when administered alone and in combination with HRS-1301 tablets. |
| Maximum observed plasma concentration (Cmax) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-last) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf) | Up to 15 days. | Plasma pharmacokinetics (PK) parameters of 1-hydroxymidazolam following administration of midazolam alone and in combination with HRS-1301 tablets. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC 0-inf) | Up to 18 days. | Plasma pharmacokinetics (PK) parameters of 2-Hydroxy Atorvastatin following administration of atorvastatin alone and in combination with HRS-1301 tablets. |
| Incidence and severity of adverse events (AEs) | Up to 22 days. | Safety and Tolerability. |
Countries
China
Contacts
CONTACTYing Wang
Outcome results
None listed