NCT05152277

Brief Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple subcutaneous injections of HRS9531 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

December 6, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

November 29, 2021

Last Update Submit

September 16, 2022

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    A summary of adverse events, including Serious Adverse Events(SAEs)

    Start of Treatment to end of study (approximately 7 weeks or 9 weeks)

Secondary Outcomes (5)

  • Area under the plasma concentration-time curve (AUC) of HRS9531

    Start of Treatment to end of study (approximately 7 weeks)

  • Immunogenicity qualitative

    Start of Treatment to end of study (approximately 7 weeks)

  • AUC of HRS9531

    Start of Treatment to end of study (approximately 9 weeks)

  • Immunogenicity qualitative

    Start of Treatment to end of study (approximately 9 weeks)

  • Glucose concentration

    Start of Treatment to end of study (approximately 9 weeks)

Study Arms (4)

Single dose escalation of HRS9531 injection in healthy subjects

EXPERIMENTAL
Drug: HRS9531

Single dose of placebo in healthy adults

PLACEBO COMPARATOR
Other: placebo

Multiple dose escalation of HRS9531 injection in healthy subjects

EXPERIMENTAL
Drug: HRS9531

Multiple dose of placebo in healthy adults

PLACEBO COMPARATOR
Other: placebo

Interventions

HRS9531DRUG

Administered SC once

Single dose escalation of HRS9531 injection in healthy subjects
placeboOTHER

Administered SC once

Single dose of placebo in healthy adults

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
  • Age 18-55 years on the date of signing informed consent (inclusive);
  • Body weight ≥50 kg, body mass index (BMI) within the range of 19.0-35.0 kg/m2 (inclusive);
  • Subjects with good general health, no clinically significant abnormalities.

You may not qualify if:

  • 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;
  • Had a severe trauma or major surgery within 6 months prior to screening, planned to undergo surgery during the trial period;
  • Participants in clinical trials of any drug or medical device in the 3 months prior to screening;
  • Blood donation history or blood loss ≥400 mL within 1 month before screening, or received blood transfusion within 2 months;
  • Allergic constitution includes severe drug allergy or history of drug allergy;
  • Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive;
  • Breast-feeding women;
  • The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: HRS9531 compared with placebo
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 9, 2021

Study Start

December 6, 2021

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations

CN(1)