Pharmacokinetics, Pharmacodynamics Profile and Tolerance of HRS-9231 in Healthy Subjects

Shanghai Shengdi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: HRS-9231; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07123376

HRS-9231-101

Details and patient eligibility

About

To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 18 to 45 years.
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion criteria

1. Patients with contraindications for magnetic resonance imaging (MRI) examinations.
2. During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
3. Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
4. Unable to tolerate venipunctures or have a history of fainting needles and blood.
5. People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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40 participants in 5 patient groups

Group 1

Experimental group

Description:

8 healthy subjects were to be included

Treatment:

Drug: Placebo

Drug: HRS-9231

Group 2

Experimental group

Description:

8 healthy subjects were to be included

Treatment:

Drug: Placebo

Drug: HRS-9231

Group 3

Experimental group

Description:

8 healthy subjects were to be included

Treatment:

Drug: Placebo

Drug: HRS-9231

Group 4

Experimental group

Description:

8 healthy subjects were to be included

Treatment:

Drug: Placebo

Drug: HRS-9231

Group 5

Experimental group

Description:

8 healthy subjects were to be included

Treatment:

Drug: Placebo

Drug: HRS-9231