Type 2 DiabetesPhase 1NCT05893576
A Relative Bioavailability Study of HRS9531 in Healthy Subjects
A Phase 1 study testing HRS9531 in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- HRS9531
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 4 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- Age 18-45 years on the date of signing informed consent (inclusive);
- Body weight ≥50 kg for male and 45 kg for female, body mass index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);
- Subjects with good general health, no clinically significant abnormalities.
Who cannot join
- 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 3 month or ≥200 mL within 1 month before screening, or received blood transfusion within 3 months;
- Allergic constitution includes severe drug allergy or history of drug allergy;
- Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;
- Breast-feeding women;
- The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Central hospital affiliated to Shandong first mecical university
Jinan, Shandong, 250014
About this study
Official title: A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.
- Conditions
- Type 2 Diabetes
- Being tested
- HRS9531
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
Receive a single dose of HRS9531 of original formulation.
HRS9531Drug
Receive a single dose of HRS9531 of new formulation.
| Study group | Role | What they receive |
|---|---|---|
| R group (reference formulation group) | Experimental | Not described Receives: Drug: HRS9531 |
| T group (test formulation group) | Experimental | Not described Receives: Drug: HRS9531 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration versus time curve (AUC) of HRS953
Measured: Start of treatment up to Day 43
Maximum Concentration (Cmax) of HRS9531
Measured: Start of Treatment up to Day 43
Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%
Measured: Start of Treatment up to Day 43
Secondary outcomes (5)
Time to maximum concentration (Tmax)
Measured: Start of Treatment up to Day 43
Apparent terminal half-life (t1/2)
Measured: Start of Treatment up to Day 43
Clearance (CL/F)
Measured: Start of Treatment up to Day 43
Apparent volume of distribution (VzF)
Measured: Start of Treatment up to Day 43
Incidence and severity of adverse events
Measured: Screening period up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 May 2023
- Primary completion4 Sep 2023
- Study completion4 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-dose, parallel design trial, consisting of two parallel groups: a reference formulation group (R: original formulation) and a test formulation group (T: new formulation). Both R and T groups receive a same dose of HRS9531.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893576
- Sponsor's protocol ID
- HRS9531-103
- Status last verified
- Oct 2023
- First submitted
- 5 May 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Single-dose, Randomized, Open-label, Single-period, Parallel Design of HRS9531 Injection Using Different Manufacturing Processes in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05893576
- Acronym / sponsor ID
- HRS9531-103
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 4 Sep 2023 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability of the new formulation of HRS9531 injection between the original formulation of HRS9531 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a single-dose, parallel design trial, consisting of two parallel groups: a reference formulation group (R: original formulation) and a test formulation group (T: new formulation). Both R and T groups receive a same dose of HRS9531.
| Arm | Type | Receives |
|---|---|---|
| R group (reference formulation group) | Experimental | Drug: HRS9531 |
| T group (test formulation group) | Experimental | Drug: HRS9531 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
- Age 18-45 years on the date of signing informed consent (inclusive);
- Body weight ≥50 kg for male and 45 kg for female, body mass index (BMI) within the range of 19.0-26.0 kg/m2 (inclusive);
- Subjects with good general health, no clinically significant abnormalities.
Key exclusion criteria (8 listed)
- 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 3 month or ≥200 mL within 1 month before screening, or received blood transfusion within 3 months;
- Allergic constitution includes severe drug allergy or history of drug allergy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS9531Receive a single dose of HRS9531 of original formulation. | Drug | R group (reference formulation group) |
| HRS9531Receive a single dose of HRS9531 of new formulation. | Drug | T group (test formulation group) |
Primary outcome
Area Under the Concentration versus time curve (AUC) of HRS953
Time frame: Start of treatment up to Day 43
Maximum Concentration (Cmax) of HRS9531
Time frame: Start of Treatment up to Day 43
Calculate the ratio of bioavailability between the new formulation and original formulation of HRS9531 according to the equation F (relative bioavailability) =AUCT·DR/AUCR·DT×100%
Time frame: Start of Treatment up to Day 43
5 secondary outcomes
Time to maximum concentration (Tmax)
Time frame: Start of Treatment up to Day 43
Apparent terminal half-life (t1/2)
Time frame: Start of Treatment up to Day 43
Clearance (CL/F)
Time frame: Start of Treatment up to Day 43
Apparent volume of distribution (VzF)
Time frame: Start of Treatment up to Day 43
Incidence and severity of adverse events
Time frame: Screening period up to Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS9531 in people with Type 2 Diabetes, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration versus time curve (AUC) of HRS953 (time frame: Start of treatment up to Day 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.