HealthyPhase 1NCT02750553
A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers
A Phase 1 study testing SHR0534 in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
This is a randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SHR0534
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have a BMI between 18 to 24.9 kg/m2, inclusive;
- Clinical laboratory tests (i.e.blood chemistries, and urinalysis) must be within the normal reference range or clinically acceptable as determined by the investigator;
- Subjects must be free of any clinically significant diseases based on medical history , physical examination and/or the investigator's judgment;
- Winthout bad habits, including smoking, drinking and others;
- Negative in Urine or serum pregnancy test for woman, female subject of childbearing potential and male subject must be willing to use an acceptable method of birth control for the duration of the study and continuing 90 days after discontinuing treatment with the investigational ;
- Subject must be able to understand the information associated with the study, and are willing to provide written informed consent.
Who cannot join
- Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
- History of surgery or major trauma within 12 weeks of study entry, or surgery planned during the study;
- History of hypersensitivity to SHR0534 or its components;
- Any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or a history of severe unconsciousness hypoglycemia judged by researchers;
- History of liver disease. Those with Alanine aminotransferase (ALT) or Aspertate aminotransferase (AST)>1.5 times upper limit of normal must be excluded;
- Severe infection, trauma or major surgery 4 weeks before screening;
Show all 16Show fewer
- Congestive heart failure and other serious heart and lung diseases that need medication;
- Have a positive test at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb);
- Positive in nicotine screening test, or cannot refrain from smoking;
- Urine drug screen test positive for ethanol, cocaine, tetrahydrocannabinol (THC), barbiturates, amphetamines, benzodiazepines, or opiates;
- Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
- Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome (CYP) P450 enzymes including CYP3A4, CYP2C8 and CYP2C9 within 28 days prior to the first dose and throughout the study;
- Use of any prescription drugs and Chinese herbal medicines within 4 weeks before randomization, or use of non prescription drugs and food supplements (vitamins, etc.) within 2 weeks before randomization;
- Participated any drug clinical trials within 3 months, or had blood donation/loss ≥500 mL within 4 weeks before randomization;
- Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization;
- Subject who is unsuitable for inclusion in the study in the opinion of he investigator.
About this study
This is a randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug or placebo.
- Conditions
- Healthy
- Being tested
- SHR0534, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0534Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pre-test | Experimental | Three healthy male subjects were randomized in 2:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
| Cohort 1 | Experimental | Eight healthy subjects were randomized in 3:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
| Cohort 2 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 10 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
| Cohort 3 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 25 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
| Cohort 4 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 50 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
| Cohort 5 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 100 mg SHR0534 or matching placebo. Receives: Drug: SHR0534; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Measured: From baseline up to 8 days after last treatment (Day 31)
Secondary outcomes (4)
Area under the plasma or urine concentration curve after single or the last multiple oral dose (AUC)
Measured: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Peak plasma concentration (Cmax) after single or the last multiple oral dose
Measured: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Terminal elimination halflife (t½) for SHR0534 after single or the last multiple oral dose
Measured: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Changes in the concentrations of blood glucose and insulin after single or multiple oral dose
Measured: From baseline up to 24 hours after last treatment (Day 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
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
- NCT02750553
- Sponsor's protocol ID
- SHR0534-Ia
- Status last verified
- Apr 2016
- First submitted
- 21 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT02750553
- Acronym / sponsor ID
- SHR0534-Ia
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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 randomized, placebo-controlled, single \& multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pre-test | Experimental | Drug: SHR0534, Drug: PlaceboThree healthy male subjects were randomized in 2:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
| Cohort 1 | Experimental | Drug: SHR0534, Drug: PlaceboEight healthy subjects were randomized in 3:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
| Cohort 2 | Experimental | Drug: SHR0534, Drug: PlaceboTen healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 10 mg SHR0534 or matching placebo. |
| Cohort 3 | Experimental | Drug: SHR0534, Drug: PlaceboTen healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 25 mg SHR0534 or matching placebo. |
| Cohort 4 | Experimental | Drug: SHR0534, Drug: PlaceboTen healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 50 mg SHR0534 or matching placebo. |
| Cohort 5 | Experimental | Drug: SHR0534, Drug: PlaceboTen healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 100 mg SHR0534 or matching placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must have a BMI between 18 to 24.9 kg/m2, inclusive;
- Clinical laboratory tests (i.e.blood chemistries, and urinalysis) must be within the normal reference range or clinically acceptable as determined by the investigator;
- Subjects must be free of any clinically significant diseases based on medical history , physical examination and/or the investigator's judgment;
- Winthout bad habits, including smoking, drinking and others;
- Negative in Urine or serum pregnancy test for woman, female subject of childbearing potential and male subject must be willing to use an acceptable method of birth control for the duration of the study and continuing 90 days after discontinuing treatment with the investigational ;
Key exclusion criteria (16 listed)
- Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator;
- History of surgery or major trauma within 12 weeks of study entry, or surgery planned during the study;
- History of hypersensitivity to SHR0534 or its components;
- Any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or a history of severe unconsciousness hypoglycemia judged by researchers;
- History of liver disease. Those with Alanine aminotransferase (ALT) or Aspertate aminotransferase (AST)>1.5 times upper limit of normal must be excluded;
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 |
|---|---|---|
| SHR0534 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Pre-test |
| Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Pre-test |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline up to 8 days after last treatment (Day 31)
4 secondary outcomes
Area under the plasma or urine concentration curve after single or the last multiple oral dose (AUC)
Time frame: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Peak plasma concentration (Cmax) after single or the last multiple oral dose
Time frame: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Terminal elimination halflife (t½) for SHR0534 after single or the last multiple oral dose
Time frame: From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose
Changes in the concentrations of blood glucose and insulin after single or multiple oral dose
Time frame: From baseline up to 24 hours after last treatment (Day 24)
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 26 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0534 in people with Healthy, 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 6 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 26 Apr 2016. 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. 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?
Number of treatment emergent adverse events (TEAEs) (time frame: From baseline up to 8 days after last treatment (Day 31)). 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 26 Apr 2016.