Inflammatory Bowel DiseasePhase 1NCT05638347
A Trial of HRS-7085 Tablet in Healthy Participants With and Without Food Effect.
A Phase 1 study testing HRS-7085 tablets in people with Inflammatory Bowel Disease, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Dec 2022to 16 Mar 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Who cannot join
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 3 months before dosing.
- Subjects with infectious disease.
- Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
- Blood donation or loss of ≥ 200 mL of blood within 1 month prior to dosing, or ≥ 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
- Clinically significant abnormalities in 12-Lead ECG
Show all 16Show fewer
- More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening, or positive cotinine test at screening or baseline.
- Positive urine drug at screening or baseline.
- Subject who cannot perform venous blood sampling.
- Known history or suspected of being allergic to the study drugs and their excipients.
- Use of prescription medicine within 2 weeks, or OTC medicine, within 1-week or 5 half-lives prior to dosing.
- History of alcohol abuse within 3 months prior to screening, or positive alcohol breath test at screening or baseline.
- Participation in clinical trials of other investigational drugs or medical devices within 1 month or 5 half-lives prior to dosing.
- Special dietary requirements that cannot follow the meal plan in the food effect study.
- In the investigator's judgment, may increase the risk to the subject.
- Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- HRS-7085 tablets, Placebo tablet
- 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
Single oral administration
Placebo tabletDrug
Single oral administration
| Study group | Role | What they receive |
|---|---|---|
| HRS-7085 tablets Cohort 1 | Experimental | Part 1- HRS-7085 tablets Receives: Drug: HRS-7085 tablets; Drug: Placebo tablet |
| HRS-7085 tablets Cohort 6 | Experimental | Part 1- HRS-7085 tablets Receives: Drug: HRS-7085 tablets; Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Measured: Start of Treatment to end of study approximately 1 week
Secondary outcomes (7)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HRS-7085 administration
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after HRS-7085 administration
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Tmax
Time to Cmax of HRS-7085
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cmax
Maximum observed concentration of HRS-7085
Measured: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-CL/F
Apparent clearance of HRS-7085
Measured: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of HRS-7085
Measured: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-t1/2
Terminal elimination half-life of HRS-7085
Measured: Time Frame: Start of Treatment to end of study (approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start5 Dec 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
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.
- 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
- Sequential
- Model description
- Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638347
- Sponsor's protocol ID
- HRS-7085-102-AUS
- Status last verified
- Apr 2023
- First submitted
- 27 Nov 2022
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05638347
- Acronym / sponsor ID
- HRS-7085-102-AUS
- Conditions
- Inflammatory Bowel Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 6 Dec 2022 (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 study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part 1: HRS-7085 Single Ascending Dose (SAD) Both males and females are planned to be enrolled in five cohorts (optional and determined by Safety Review Committee (SRC) in this SAD study Part 2: Food Effect: Participants in cohort 3 who have finished the follow-up visit will be involved in the food effect study after safety evaluation by the investigator.
| Arm | Type | Receives |
|---|---|---|
| HRS-7085 tablets Cohort 1 | Experimental | Drug: HRS-7085 tablets, Drug: Placebo tabletPart 1- HRS-7085 tablets |
| HRS-7085 tablets Cohort 6 | Experimental | Drug: HRS-7085 tablets, Drug: Placebo tabletPart 1- HRS-7085 tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight 45 kg~100 kg (inclusive) at screening, and body mass index (BMI) between 18 and 32 kg/m2 (inclusive).
- For healthy subjects, no clinically significant abnormalities.
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Key exclusion criteria (16 listed)
- Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
- Severe injuries or major surgeries within 3 months before dosing.
- Subjects with infectious disease.
- Live/attenuated vaccine within 3 months prior to dosing or any vaccine during the trial.
- Blood donation or loss of ≥ 200 mL of blood within 1 month prior to dosing, or ≥ 400 mL of blood within 3 months prior to dosing; or receive a blood transfusion within 2 months prior to dosing.
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 tabletsSingle oral administration | Drug | HRS-7085 tablets Cohort 1, HRS-7085 tablets Cohort 6 |
| Placebo tabletSingle oral administration | Drug | HRS-7085 tablets Cohort 1, HRS-7085 tablets Cohort 6 |
Primary outcome
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study approximately 1 week
7 secondary outcomes
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cmax
Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-CL/F
Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Vz/F
Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-t1/2
Time frame: Time Frame: Start of Treatment to end of study (approximately 1 week)
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 21 Apr 2023.
Related trials for Inflammatory Bowel Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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-7085 tablets in people with Inflammatory Bowel Disease, run by Atridia Pty Ltd. at 1 site in Australia.
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 16 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 21 Apr 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 Australia. 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?
Incidence and severity of adverse events (time frame: Start of Treatment to end of study approximately 1 week). 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 21 Apr 2023.