Healthy VolunteersPhase 1NCT06514963
A Trial of HRS-9813 in Healthy Volunteers
A Phase 1 study testing HRS-9813 in people with Healthy Volunteers, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HRS-9813
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 2 Jan 2025
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- Male or female aged 18-55 (adult healthy volunteers);
- Body mass index (BMI) between 19 and 26 kg/m2;
- Normal Electrocardiogram (ECG);
- Men and women of childbearing potential must agree to take effective contraceptive methods.
Who cannot join
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
- History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
- Seated systolic blood pressure (SBP) of <90 mmHg or seated diastolic blood pressure (DBP) of <60 mmHg;
- Patients with orthostatic hypotension;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect on the Pharmacokinetics of HRS-9813 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- HRS-9813, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9813Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo Receives: Drug: HRS-9813; Drug: Placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo Receives: Drug: HRS-9813; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Measured: 7 days (SAD), 14 days (MAD)
Secondary outcomes (10)
PK parameter of HRS-9813: Area under the concentration time curve (AUC)
Measured: Days 1-9
PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)
Measured: Days 1-9
PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)
Measured: Days 1-9
PK parameter of HRS-9813: Half-life (t1/2)
Measured: Days 1-9
PK parameter of HRS-9813: Apparent clearance (CL/F)
Measured: Days 1-9
PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)
Measured: Days 1-9
PK parameter of HRS-9813: Accumulation ratio (Racc)
Measured: Days 1-9
PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine
Measured: Days 1-2
PK parameter of HRS-9813: Fractional excretion (fe) in the urine
Measured: Days 1-2
PK parameter of HRS-9813: Renal clearance (CLR)
Measured: Days 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start24 Jul 2024
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- HRS-9813 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514963
- Sponsor's protocol ID
- HRS-9813-101
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 8 Jan 2025
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect on the Pharmacokinetics of HRS-9813 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06514963
- Acronym / sponsor ID
- HRS-9813-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 23 Jul 2024 (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 phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HRS-9813 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Drug: HRS-9813, Drug: PlaceboSubjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Drug: HRS-9813, Drug: PlaceboSubjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- Male or female aged 18-55 (adult healthy volunteers);
- Body mass index (BMI) between 19 and 26 kg/m2;
- Normal Electrocardiogram (ECG);
- Men and women of childbearing potential must agree to take effective contraceptive methods.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
- History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
- Seated systolic blood pressure (SBP) of <90 mmHg or seated diastolic blood pressure (DBP) of <60 mmHg;
- Patients with orthostatic hypotension;
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
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 |
|---|---|---|
| HRS-9813Specified dose on specified days | Drug | multiple ascending dose (MAD) cohorts, single ascending dose (SAD) cohorts |
| PlaceboSpecified dose on specified days | Drug | multiple ascending dose (MAD) cohorts, single ascending dose (SAD) cohorts |
Primary outcome
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Time frame: 7 days (SAD), 14 days (MAD)
10 secondary outcomes
PK parameter of HRS-9813: Area under the concentration time curve (AUC)
Time frame: Days 1-9
PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)
Time frame: Days 1-9
PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)
Time frame: Days 1-9
PK parameter of HRS-9813: Half-life (t1/2)
Time frame: Days 1-9
PK parameter of HRS-9813: Apparent clearance (CL/F)
Time frame: Days 1-9
PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)
Time frame: Days 1-9
PK parameter of HRS-9813: Accumulation ratio (Racc)
Time frame: Days 1-9
PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine
Time frame: Days 1-2
PK parameter of HRS-9813: Fractional excretion (fe) in the urine
Time frame: Days 1-2
PK parameter of HRS-9813: Renal clearance (CLR)
Time frame: Days 1-2
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 8 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 HRS-9813 in people with Healthy Volunteers, run by Guangdong Hengrui 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 5 inclusion and 5 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 8 Jan 2025. 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?
Safety: incidence of adverse event (AE), serious adverse event (SAE) (time frame: 7 days (SAD), 14 days (MAD)). 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 8 Jan 2025.