This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.
Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial.
The age range is from 18 to 55 years old (inclusive at both ends).
Weight ≥ 50.0 kg.
They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners).
During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered.
The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points.
During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc.
Diabetes (except gestational diabetes).
Parallel
HRS-1596
DrugHRS-1596.
HRS-1596 Placebo
DrugHRS-1596 placebo.
The incidence and severity of adverse events (AEs)
The maximum plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Terminal half-life (t1/2)
Anti-HRS-1596 Antibodies (ADAs)
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This trial is not recruiting at the moment. You can still explore other options:
