Inflammatory Bowel DiseasePhase 1NCT06175949
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects
A Phase 1 study testing HRS-7085 Tablets and HRS-7085 simulant in people with Inflammatory Bowel Disease, run by Shandong Suncadia Medicine Co., Ltd..
Trial summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets in healthy subjects, with assessment of food effects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- HRS-7085 Tablets and HRS-7085 simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2024
- 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
- Adults aged 18 to 55 years (inclusive), of any gender (each dose group should include at least two subjects of a single gender, except for the 2 mg dose group in Part 1A).
- Body Mass Index (BMI = weight/height^2) during screening: 19 ≤ BMI < 28 kg/m^2; male weight ≥ 50.0 kg and < 90.0 kg, female weight ≥ 45.0 kg and < 90.0 kg.
- Healthy subjects with physical examination, vital signs, and laboratory test results (including complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function), chest X-ray, 12-lead electrocardiogram, abdominal ultrasound, judged by the investigator as normal or clinically insignificant abnormalities during screening.
- Female subjects of reproductive potential and male subjects with female partners of reproductive potential must have no plans for reproduction, sperm/egg donation for at least 3 months after the last dose and voluntarily agree to use effective contraception. Serum pregnancy test for female subjects must be negative and not in lactation.
- Obtain informed consent before any trial-related activities begin, fully understand the purpose and significance of this trial, and be willing to comply with the trial protocol.
Who cannot join
- Within the past year prior to screening or dosing, individuals with systemic diseases such as cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, or hematologic conditions, deemed by the investigator to pose potential safety risks.
- Within the past 6 months prior to screening or dosing, individuals with a history of severe infections (such as bloodstream infections, central nervous system infections, abdominal infections, etc.), severe trauma, or major surgeries (excluding appendectomy); those planning to undergo surgery during the trial.
- Within the past month prior to screening or dosing, individuals with a history of infections (viral, bacterial, fungal, parasitic) requiring systemic antimicrobial therapy.
- Individuals experiencing frequent headaches, nausea, and/or vomiting with a frequency of ≥3 times per month.
- Individuals with allergic tendencies, such as a history of asthma, atopic dermatitis, chronic urticaria, allergic rhinitis, or any known allergies to drugs or foods.
- Within the past month prior to screening or dosing, individuals who donated blood or experienced blood loss ≥200 mL, or within the past 3 months prior to dosing, individuals who donated blood or experienced blood loss ≥400 mL.
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- As determined by the study physician, individuals with any physiological or psychological condition that may increase trial risks, affect subject compliance with the protocol, or interfere with subject completion of the trial.
- Individuals with a smoking history within the past 3 months prior to screening (average daily smoking >5 cigarettes) or those unable to abstain from any tobacco products during the trial.
- Within the past month prior to screening, individuals with an average daily alcohol intake exceeding 7 g for females (equivalent to approximately 200 mL of beer, 70 mL of wine, or 22 mL of spirits) or exceeding 14 g for males (equivalent to approximately 400 mL of beer, 140 mL of wine, or 45 mL of spirits); or individuals with a positive alcohol test at screening or those unable to abstain from alcohol during the trial.
- Individuals who consumed any grapefruit-containing foods or beverages within 7 days prior to taking the study drug, or those who consumed caffeine-containing foods or beverages within 2 days prior to taking the study drug.
- Individuals with special dietary requirements who cannot adhere to a standardized diet.
- Individuals with a history of drug abuse or substance misuse, or those with a positive urine drug screen at screening.
- Individuals with positive results in infectious disease screening tests (HBsAg, anti-HCV Ab, anti-TP Ab, anti-HIV Ab) at screening.
- Individuals with alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin (TBIL) levels ≥1.5 times the upper limit of normal (ULN) at screening.
- Within 2 weeks prior to screening or dosing, individuals who used any prescription medications, over-the-counter medications, or herbal supplements; or individuals within 5 half-lives of a drug (whichever is longer) at screening or planning to use non-study investigational drug during the trial.
- Within the past 3 months prior to screening, individuals who participated in any other clinical trial (excluding those who failed screening) or those still within 5 half-lives of a drug (whichever is longer) at screening.
- Within the past 3 months prior to screening, individuals who received a live vaccine or attenuated live vaccine, or those planning to receive any vaccines during the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-7085 Tablets Following Single and Multiple Oral Administrations, With Evaluation of Food Effects in Healthy Subjects
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets in healthy subjects, with assessment of food effects
- Conditions
- Inflammatory Bowel Disease
- Being tested
- HRS-7085 Tablets, HRS-7085 simulant
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-7085 TabletsDrug
HRS-7085 Tablets, PO, 2mg、5mg、8mg、10mg、12mg、15mg, QD,
HRS-7085 simulantDrug
PO, 2mg、5mg、8mg、10mg、12mg、15mg, QD
| Study group | Role | What they receive |
|---|---|---|
| HRS-7085 | Experimental | Not described Receives: Drug: HRS-7085 Tablets |
| HRS-7085 simulant | Placebo comparator | Not described Receives: Drug: HRS-7085 simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 7 days or 20 days,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175949
- Sponsor's protocol ID
- HRS-7085-101
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 19 Dec 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-7085 Tablets Following Single and Multiple Oral Administrations, With Evaluation of Food Effects in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06175949
- Acronym / sponsor ID
- HRS-7085-101
- Conditions
- Inflammatory Bowel Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Dec 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.
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets in healthy subjects, with assessment of food effects
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 |
|---|---|---|
| HRS-7085 | Experimental | Drug: HRS-7085 Tablets |
| HRS-7085 simulant | Placebo comparator | Drug: HRS-7085 simulant |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 55 years (inclusive), of any gender (each dose group should include at least two subjects of a single gender, except for the 2 mg dose group in Part 1A).
- Body Mass Index (BMI = weight/height^2) during screening: 19 ≤ BMI < 28 kg/m^2; male weight ≥ 50.0 kg and < 90.0 kg, female weight ≥ 45.0 kg and < 90.0 kg.
- Healthy subjects with physical examination, vital signs, and laboratory test results (including complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function), chest X-ray, 12-lead electrocardiogram, abdominal ultrasound, judged by the investigator as normal or clinically insignificant abnormalities during screening.
- Female subjects of reproductive potential and male subjects with female partners of reproductive potential must have no plans for reproduction, sperm/egg donation for at least 3 months after the last dose and voluntarily agree to use effective contraception. Serum pregnancy test for female subjects must be negative and not in lactation.
- Obtain informed consent before any trial-related activities begin, fully understand the purpose and significance of this trial, and be willing to comply with the trial protocol.
Key exclusion criteria (17 listed)
- Within the past year prior to screening or dosing, individuals with systemic diseases such as cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, or hematologic conditions, deemed by the investigator to pose potential safety risks.
- Within the past 6 months prior to screening or dosing, individuals with a history of severe infections (such as bloodstream infections, central nervous system infections, abdominal infections, etc.), severe trauma, or major surgeries (excluding appendectomy); those planning to undergo surgery during the trial.
- Within the past month prior to screening or dosing, individuals with a history of infections (viral, bacterial, fungal, parasitic) requiring systemic antimicrobial therapy.
- Individuals experiencing frequent headaches, nausea, and/or vomiting with a frequency of ≥3 times per month.
- Individuals with allergic tendencies, such as a history of asthma, atopic dermatitis, chronic urticaria, allergic rhinitis, or any known allergies to drugs or foods.
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-7085 TabletsHRS-7085 Tablets, PO, 2mg、5mg、8mg、10mg、12mg、15mg, QD, | Drug | HRS-7085 |
| HRS-7085 simulantPO, 2mg、5mg、8mg、10mg、12mg、15mg, QD | Drug | HRS-7085 simulant |
Primary outcome
Adverse events
Time frame: 7 days or 20 days,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-7085 Tablets and HRS-7085 simulant in people with Inflammatory Bowel Disease, run by Shandong Suncadia Medicine Co., Ltd..
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 17 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Gao (0518-82342973, xin.gao.xg26@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 7 days or 20 days,). 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 19 Dec 2023; AzTrials last refreshed its copy on 2 Nov 2026.