PainPhase 1NCT04573036
A Trial of HRS4800 Tables in Healthy Male Subjects
A Phase 1 study testing HRS4800 tablets in people with Pain, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- HRS4800 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Nov 2020to 20 Sep 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
- Male aged between 18 years and 55 years at screening, inclusive.
- Total body weight ≥50 kg at screening, and body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Agree to practice true abstinence; be surgically sterilised (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom if sexually active with a female partner of childbearing potential for at least 3 months after dosing.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator. Male aged between 18 years and 55 years at screening, inclusive.
Who cannot join
- History of severe digestive system disease or having a digestive disease currently within a month of screening or before first dosing, and may affect drug absorption or have safety risks.
- Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
- Use of any medicine affecting liver metabolism within 1 month of screening (see Appendix 1); use of any prescription medications within 14 days or 5 half-lives prior to dosing, use of any over-the-counter medicine or herbal products within 7 days prior to dosing; intention to use any other medicine during the trial.
- Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or plasma donation within 14 days prior to dosing; or received blood within 8 weeks prior to dosing.
- History of allergy to the study drug or any component of it.
- History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks: 1 drink=5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor).
Show all 10Show fewer
- Subject has used more than 5 tobacco or nicotine-containing products per day in the 6 months prior to dosing and is unable to refrain from use of such products from at least 48 hours prior to check-in through to the final study visit.
- Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.
- History of drug abuse within 2 years prior to screening.
- Other conditions or laboratory abnormality that may increase the risk associated with study participation or IP administration or interfere with the interpretation of study results and, at the discretion of the investigator, makes the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Participants
This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.
- Conditions
- Pain
- Being tested
- HRS4800 tablets, Placebo tablets
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS4800 tabletsDrug
single oral administration
Placebo tabletsDrug
single oral administration
| Study group | Role | What they receive |
|---|---|---|
| HRS4800 tablets cohort 1 | Experimental | Part 1 - HRS4800 Single Ascending Dose Receives: Drug: HRS4800 tablets |
| HRS4800 tablets cohort 2 | Experimental | Part 1 - HRS4800 Single Ascending Dose Receives: Drug: HRS4800 tablets |
| HRS4800 tablets cohort 3 | Experimental | Part 1 - HRS4800 Single Ascending Dose Receives: Drug: HRS4800 tablets |
| HRS4800 tablets cohort 4 | Experimental | Part 1 - HRS4800 Single Ascending Dose Receives: Drug: HRS4800 tablets |
| HRS4800 tablets cohort 5 | Experimental | Part 2 - HRS4800 Food Effect Receives: Drug: HRS4800 tablets |
| Placebo tablets | Placebo comparator | Not described Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 - HRS4800 Single Dose Escalation - Safety
- Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc.
Measured: 14 days
Part 2 - HRS4800 Food Effect
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t
Measured: 21 days
Part 2 - HRS4800 Food Effect
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-∞
Measured: 21 days
Part 2 - HRS4800 Food Effect
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: Tmax、
Measured: 21 days
Part 2 - HRS4800 Food Effect
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: Cmax
Measured: 21 days
Part 2 - HRS4800 Food Effect
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: t1/2、CL/F、Vz/F.
Measured: 21 days
Secondary outcomes (6)
Part 1 - HRS4800 Single Dose Escalation - PK
- PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t
Measured: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
AUC0-∞、
Measured: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Tmax
Measured: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Cmax
Measured: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
t1/2
Measured: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
CL/F、Vz/F.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start12 Nov 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- The study consists of 2 parts: single dose escalation (Part 1) with four cohorts and food effect on HRS4800 PK (Part 2) with one cohort. All cohorts can enroll healthy male subjects
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Na Li, Study director, Jiangsu Hengrui Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573036
- Sponsor's protocol ID
- HRS4800-I-101-AUS
- Status last verified
- Jul 2021
- First submitted
- 16 Sep 2020
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT04573036
- Acronym / sponsor ID
- HRS4800-I-101-AUS
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 5 Oct 2020 (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 single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- The study consists of 2 parts: single dose escalation (Part 1) with four cohorts and food effect on HRS4800 PK (Part 2) with one cohort. All cohorts can enroll healthy male subjects
| Arm | Type | Receives |
|---|---|---|
| HRS4800 tablets cohort 1 | Experimental | Drug: HRS4800 tabletsPart 1 - HRS4800 Single Ascending Dose |
| HRS4800 tablets cohort 2 | Experimental | Drug: HRS4800 tabletsPart 1 - HRS4800 Single Ascending Dose |
| HRS4800 tablets cohort 3 | Experimental | Drug: HRS4800 tabletsPart 1 - HRS4800 Single Ascending Dose |
| HRS4800 tablets cohort 4 | Experimental | Drug: HRS4800 tabletsPart 1 - HRS4800 Single Ascending Dose |
| HRS4800 tablets cohort 5 | Experimental | Drug: HRS4800 tabletsPart 2 - HRS4800 Food Effect |
| Placebo tablets | Placebo comparator | Drug: Placebo tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
- Male aged between 18 years and 55 years at screening, inclusive.
- Total body weight ≥50 kg at screening, and body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Agree to practice true abstinence; be surgically sterilised (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom if sexually active with a female partner of childbearing potential for at least 3 months after dosing.
- No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator. Male aged between 18 years and 55 years at screening, inclusive.
Key exclusion criteria (10 listed)
- History of severe digestive system disease or having a digestive disease currently within a month of screening or before first dosing, and may affect drug absorption or have safety risks.
- Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
- Use of any medicine affecting liver metabolism within 1 month of screening (see Appendix 1); use of any prescription medications within 14 days or 5 half-lives prior to dosing, use of any over-the-counter medicine or herbal products within 7 days prior to dosing; intention to use any other medicine during the trial.
- Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or plasma donation within 14 days prior to dosing; or received blood within 8 weeks prior to dosing.
- History of allergy to the study drug or any component of it.
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 |
|---|---|---|
| HRS4800 tabletssingle oral administration | Drug | HRS4800 tablets cohort 1, HRS4800 tablets cohort 2, HRS4800 tablets cohort 3, HRS4800 tablets cohort 4, HRS4800 tablets cohort 5 |
| Placebo tabletssingle oral administration | Drug | Placebo tablets |
Primary outcome
Part 1 - HRS4800 Single Dose Escalation - Safety
Time frame: 14 days
• Safety: Incidence and severity of adverse events (AEs), vital signs (pulse rate, respiratory rate, blood pressure, body temperature), physical examination, laboratory tests, electrocardiogram (ECG), etc.
Part 2 - HRS4800 Food Effect
Time frame: 21 days
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-t
Part 2 - HRS4800 Food Effect
Time frame: 21 days
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: AUC0-∞
Part 2 - HRS4800 Food Effect
Time frame: 21 days
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Tmax、
Part 2 - HRS4800 Food Effect
Time frame: 21 days
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: Cmax
Part 2 - HRS4800 Food Effect
Time frame: 21 days
• PK parameters of HRS4800 and its active drug SHR175593 in plasma: t1/2、CL/F、Vz/F.
6 secondary outcomes
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
Part 1 - HRS4800 Single Dose Escalation - PK
Time frame: 14 days
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 31 Mar 2022.
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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.
Na Li study director
Jiangsu Hengrui Pharmaceutical Co., Ltd.
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 HRS4800 tablets in people with Pain, 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 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: finished, as of the sponsor's last update on 31 Mar 2022. 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. 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?
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?
Part 1 - HRS4800 Single Dose Escalation - Safety (time frame: 14 days). The study lists 6 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 31 Mar 2022.