PainPhase 1NCT04862884
A Trial to Evaluate the Safety and PK Profile of HRS4800 in Healthy Subjects
A Phase 1 study testing HRS4800 tablets in people with Pain, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo. 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
- 50 participants
- Where
- No sites listed yet
- Study dates
- 3 May 2021to 24 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 19.0 and 26.0 kg/m2, inclusive.
- Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
- 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.
Who cannot join
- History of severe digestive system disease or having a digestive disease currently within 3 months 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.
- ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
- Subject's supine systolic BP is ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg at screening or before first dosing.
- Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
- Positive drug screening tests,.
- 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 received blood within 2 months prior to dosing.
- History of allergy to the study drug or any component of it.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, on the Pharmacokinetics of HRS4800 in Healthy Male Subjects
The study will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.
- Conditions
- Pain
- Being tested
- HRS4800 tablets, placebo
- 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
- Drug: HRS4800 tablets Low-dose group, single oral administration
- Drug: HRS4800 tablets Low-medium dose group, single oral administration
- Drug: HRS4800 tablets medium -dose group, single oral administration
- Drug: HRS4800 tablets Medium and high dose group, single oral administration
- Drug: HRS4800 tablets High-dose group, single oral administration
placeboDrug
- Drug: placebo Low-dose group, single oral administration
- Drug: placebo Low-medium dose group, single oral administration
- Drug: placebo medium -dose group, single oral administration
- Drug: placebo Medium and high dose group, single oral administration
- Drug: placebo High-dose group, single oral administration
| Study group | Role | What they receive |
|---|---|---|
| HRS4800 tablets | Experimental | Not described Receives: Drug: HRS4800 tablets |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Adverse Events (AEs)
Measured: 1-21 days
Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Measured: 1-21 days
Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Measured: 1-21 days
Proportion of Participants with Vital Sign and Physical Examinations Abnormalities
Measured: 1-21 days
Secondary outcomes (9)
Maximum Observed Plasma Concentration (Cmax) of HRS4800,
Measured: 1-6 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,
Measured: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,
Measured: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800
Measured: 1-6 days
Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,
Measured: 1-6 days
Elimination Rate Constant (λz, or kel) of HRS4800,
Measured: 1-6 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800
Measured: 1-6 days
Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)
Measured: 1-6 days
Total HRS4800 of Fraction of Dose Excreted in Urine (feu)
Measured: 1-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start3 May 2021 (estimated)
- Primary completion3 Sep 2021 (estimated)
- Study completion24 Sep 2021 (estimated)
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.
- More trials run by Jiangsu HengRui 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
- Model description
- HRS4800 tablets single administration in healthy male
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862884
- Sponsor's protocol ID
- HRS4800-101
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. 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, on the Pharmacokinetics of HRS4800 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04862884
- Acronym / sponsor ID
- HRS4800-101
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 May 2021 (estimated)
- Primary completion
- 3 Sep 2021 (estimated)
- Study completion
- 24 Sep 2021 (estimated)
- First posted
- 28 Apr 2021 (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 will be conducted to evaluate the safety and PK profile of HRS4800 tablets after single oral administration in different dose levels compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- HRS4800 tablets single administration in healthy male
| Arm | Type | Receives |
|---|---|---|
| HRS4800 tablets | Experimental | Drug: HRS4800 tablets |
| placebo | Placebo comparator | Drug: placebo |
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 19.0 and 26.0 kg/m2, inclusive.
- Agree to take contraceptive measures and promise not to donate sperm since signing the informed consent form, to 3 months after the administration.
- 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.
Key exclusion criteria (8 listed)
- History of severe digestive system disease or having a digestive disease currently within 3 months 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.
- ALT, AST, ALP or total bilirubin level exceeds the upper limit of normal (ULN) during screening/baseline visits.
- Subject's supine systolic BP is ≥140 mmHg or <90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg at screening or before first dosing.
- Positive breath alcohol test after confirmation in a repeat test during screening/baseline visits.
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 tablets1. Drug: HRS4800 tablets Low-dose group, single oral administration 2. Drug: HRS4800 tablets Low-medium dose group, single oral administration 3. Drug: HRS4800 tablets medium -dose group, single oral administration 4. Drug: HRS4800 tablets Medium and high dose group, single oral administration 5. Drug: HRS4800 tablets High-dose group, single oral administration | Drug | HRS4800 tablets |
| placebo1. Drug: placebo Low-dose group, single oral administration 2. Drug: placebo Low-medium dose group, single oral administration 3. Drug: placebo medium -dose group, single oral administration 4. Drug: placebo Medium and high dose group, single oral administration 5. Drug: placebo High-dose group, single oral administration | Drug | placebo |
Primary outcome
Proportion of Participants with Adverse Events (AEs)
Time frame: 1-21 days
Proportion of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Time frame: 1-21 days
Proportion of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Time frame: 1-21 days
Proportion of Participants with Vital Sign and Physical Examinations Abnormalities
Time frame: 1-21 days
9 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of HRS4800,
Time frame: 1-6 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of HRS4800,
Time frame: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of HRS4800,
Time frame: 1-6 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of HRS4800
Time frame: 1-6 days
Apparent Terminal Elimination Half-Life (t1/2) of HRS4800,
Time frame: 1-6 days
Elimination Rate Constant (λz, or kel) of HRS4800,
Time frame: 1-6 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of HRS4800
Time frame: 1-6 days
Total HRS4800 of Cumulative Amount Excreted in Urine (Aeu)
Time frame: 1-6 days
Total HRS4800 of Fraction of Dose Excreted in Urine (feu)
Time frame: 1-6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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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 HRS4800 tablets in people with Pain, run by Jiangsu HengRui 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 8 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 28 Apr 2021. 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 li Yue (86-021-61623632, li.yue@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Adverse Events (AEs) (time frame: 1-21 days). The study lists 4 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 28 Apr 2021.