Atopic DermatitisPhase 1NCT07698756
A Clinical Study of HRS-8797 in Healthy Participants
A Phase 1 study testing HRS-8797 in people with Atopic Dermatitis, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- HRS-8797
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy men and women aged 18 to 55 years old at informed consent signing
- Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline
- Have no clinically significant abnormalities at screening and baseline
- Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm/egg donation
Who cannot join
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
- Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.
- Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.
- History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned
- participation during the trial; within 5 half-lives of a prior drug (whichever is longer).
- Smoking history (≥5 cigarettes/day) within 4 weeks before screening; inability to abstain from tobacco during the trial;
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- Positive for HBsAg, HIV antibody, Treponema pallidum antibody or HCV antibody at screening.
- Special dietary requirements and inability to comply with the unified diet.
- Difficulty in swallowing/venous blood collection; intolerance to intensive blood sampling.
- Other circumstances deemed unsuitable for trial participation by Researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Jilin University
Changchun, Jilin, 130000
Xiaojiao Li
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 Tablets in Healthy Subjects
The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.
- Conditions
- Atopic Dermatitis
- Being tested
- HRS-8797, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-8797Drug
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 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo Receives: Drug: HRS-8797; Drug: Placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Subjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo Receives: Drug: HRS-8797; 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: Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)
Secondary outcomes (4)
PK parameter of HRS-8797 : Area under the concentration time curve (AUC)
Measured: Days 1-19
PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax)
Measured: Days 1-19
PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax)
Measured: Days 1-19
PK parameter of HRS-8797 : Apparent clearance (CL/F)
Measured: Days 1-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698756
- Sponsor's protocol ID
- HRS-8797-101
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect Following Single and Multiple Oral Doses of HRS-8797 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07698756
- Acronym / sponsor ID
- HRS-8797-101
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Jul 2026 (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, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single ascending dose (SAD) cohorts | Experimental | Drug: HRS-8797, Drug: PlaceboSubjects will be assigned to one of 5-6 planned dose cohorts and receive single dose of HRS-8797 or placebo |
| multiple ascending dose (MAD) cohorts | Experimental | Drug: HRS-8797, Drug: PlaceboSubjects will be assigned to one of 3 planned dose cohorts and receive multiple doses of HRS-8797 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18 to 55 years old at informed consent signing
- Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline
- Have no clinically significant abnormalities at screening and baseline
- Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm/egg donation
Key exclusion criteria (10 listed)
- A history or current severe diseases of multiple systems, or other diseases interfering with trial results.
- Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.
- Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.
- History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned
- participation during the trial; within 5 half-lives of a prior drug (whichever is longer).
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-8797Specified 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: Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)
4 secondary outcomes
PK parameter of HRS-8797 : Area under the concentration time curve (AUC)
Time frame: Days 1-19
PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax)
Time frame: Days 1-19
PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax)
Time frame: Days 1-19
PK parameter of HRS-8797 : Apparent clearance (CL/F)
Time frame: Days 1-19
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
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-8797 in people with Atopic Dermatitis, run by Chengdu Suncadia Medicine 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 10 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beibei Xu (+86 0518-82342973, beibei.xu.bx53@hengrui.com), or a site near the patient. 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: Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (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 13 Jul 2026.