A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

NCT06435676 | Completed Phase 1

• 1 other identifier: HRS9531-T-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS9531tablets in healthy subjects.

Conditions

Overweight or Obesity; Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• SAD Stage: Number of Adverse Events

  36 days

• MAD Stage: Number of Adverse Events

  63 days

Secondary Outcomes (7)

• Plasma Concentration-Time to Peak (Tmax) of HRS9531

  36 days

• Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

  36 days

• Immunogenicity qualitative

  36 days

• Plasma Concentration-Time to Peak (Tmax) of HRS9531

  63 days

• Area Under the Plasma Concentration-Time Curve (AUC) of HRS9531

  63 days

Study Arms (4)

SAD Stage: HRS9531

EXPERIMENTAL

Administered po once

Drug: HRS9531

SAD Stage: placebo

PLACEBO COMPARATOR

Administered po once

Drug: Placebo

MAD Stage: HRS9531

EXPERIMENTAL

Administered po for multiple dose

Drug: HRS9531

MAD Stage: placebo

PLACEBO COMPARATOR

Administered po for multiple dose

Drug: Placebo

Interventions

HRS9531 DRUG

Single dose escalation of HRS9531 tablets in healthy subjects

SAD Stage: HRS9531

Placebo DRUG

Single dose of placebo in healthy adults

SAD Stage: placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to understand the trial procedures, be able and willing to provide a written informed consent.
• years of age at the time of signing informed consent.
• SAD stage: Body weight ≥50 kg,19.0 ≤BMI≤ 35.0 kg/m2 at screening visit. MAD stage: 24.0 ≤BMI≤ 35.0 kg/m2 at screening visit.
• Subjects with good general health, no clinically significant abnormalities.

You may not qualify if:

• Known or suspected hypersensitivity to trial product(s) or related products.
• With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.
• Abnormal and clinically significant blood pressure at screening.
• Blood donation within 1 month prior to screening, or blood donation ≥400 mL or blood loss ≥400 mL within 3 months prior to screening.
• Participation in other clinical trials.
• Presence of any clinically significant results in examination at screening visit.
• Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive.
• Presence of - clinically significant ECG results.
• Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive.
• Addiction to tobacco and alcohol.
• In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Hospital Of Anhui medical University

Hefei, Anhui, 230601, China

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: June 4, 2024
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)