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Safety and Pharmacokinetics of HRS-1597 Tablets in Healthy and Obese Participants: A Phase 1 Study

ConditionObese and Metabolic Disorders
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 to 55 years (inclusive), both male and female.

Part 1 (SAD + FE): Male body weight ≥ 50 kg, female body weight ≥ 45 kg; BMI within 19-26 kg/m² (inclusive).

Male and female participants of childbearing potential and their partners agree to have no plans for pregnancy or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last dose, and voluntarily agree to use highly effective contraceptive measures. Female participants of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose (baseline period), and must not be lactating.

Disqualifiers

Smoking more than 5 cigarettes (or other nicotine-containing products) per day within 3 months prior to screening, or planning to use any tobacco products during the study period.

History of needle phobia or blood phobia, poor venous access, difficulty in blood collection, or inability to tolerate venipuncture.

Clinically significant abnormalities in physical examination, vital signs, laboratory tests (including complete blood count, urinalysis, blood biochemistry, and coagulation function), chest imaging, abdominal ultrasound, or 12-lead electrocardiogram (ECG), as judged by the investigator.

Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), syphilis antibody, or human immunodeficiency virus (HIV) antibody.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-1597

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: single ascending dose (SAD) cohortsExperimental treatment 2 interventions
Group B: multiple ascending dose (MAD) cohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety: incidence of adverse event (AE), serious adverse event (SAE)

Time frame
10 days (SAD), 41 days (MAD)

Secondary outcomes

1

PK parameters of HRS-1597 in plasma and urine : Cmax

Time frame
Days 1-34
2

PK parameters of HRS-1597 in plasma and urine : Tmax

Time frame
Days 1-34
3

PK parameters of HRS-1597 in plasma and urine : AUC

Time frame
Days 1-34
4

PK parameters of HRS-1597 in plasma and urine : CL/F

Time frame
Days 1-34

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: