HypertensionPhase 1NCT03255993
The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People
A Phase 1 study testing SPH3127 50mg and SPH3127 100mg in people with Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- SPH3127 50mg and SPH3127 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2017to 20 Sep 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The body mass index is 18-28kg/m2 (including the critical value), which allows the minimum weight of men to be 50kg (including the critical value) and 45kg for women (including the critical value).
- Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
- Participant has understood the research's procedure and sign the informed consent .
Who cannot join
- Participant who are Pregnancy, lactating women, and planned trials begin within six months of pregnancy
- Participant who has abnormal Physical examination, laboratory examination results and clinical significance (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
- Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
- Participant who has drug allergy history and anaphylactic reaction
- Participant who took oral contraceptive in 6 months
- Participant who used any drug (including Chinese herbal medicine) within 1 week.
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- Participant who donated blood within 2 months
- Participant who participated clinical trials of any drug in 3 months (as subjects)
- Participant who has any positive result of virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) - immunoglobulin G(IgG) antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP)
- Participant who are used to smoke, alcohol abuse, eat coffee and strong tea and drug abuse
- Participant who the researchers believe that there are volunteers who are not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site
The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People
This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing
Read the detailed description
Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.
- Conditions
- Hypertension
- Being tested
- SPH3127 50mg, SPH3127 100mg, Placebo matching to SPH3127 50mg, Placebo matching to SPH3127 100mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127 50mgDrug
Also called SPH3127 is a new study drug for hypertension
SPH3127 50mg
SPH3127 100mgDrug
Also called SPH3127 is a new study drug for hypertension
SPH3127 100mg
Placebo matching to SPH3127 50mgDrug
Also called Placebo is oral tablet to matching to SPH3127 50mg
Placebo matching to SPH3127 50mg
Placebo matching to SPH3127 100mgDrug
Also called Placebo is oral tablet to matching to SPH3127 50mg
Placebo matching to SPH3127 100mg
| Study group | Role | What they receive |
|---|---|---|
| SPH3127 100mg | Experimental | A single dose of SPH3127 50 mg*2 qd *7 days Receives: Drug: SPH3127 50mg |
| Placebo to SPH3127 100mg | Placebo comparator | A single dose of placebo matching to SPH3127 50mg*2 qd *7 days Receives: Drug: Placebo matching to SPH3127 50mg |
| SPH3127 200mg | Experimental | A single dose of SPH3127 100 mg*2 qd *7 days Receives: Drug: SPH3127 100mg |
| Placebo to SPH3127 200mg | Placebo comparator | A single dose of placebo matching to SPH3127 100mg*2 qd *7 days Receives: Drug: Placebo matching to SPH3127 100mg |
| SPH3127 400mg | Experimental | A single dose of SPH3127 100 mg*4 qd *7 days Receives: Drug: SPH3127 100mg |
| Placebo to SPH3127 400mg | Placebo comparator | A single dose of placebo matching to SPH3127 100mg*4 qd *7 days Receives: Drug: Placebo matching to SPH3127 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127
Measured: Baseline to 13-16 days post last dose
Secondary outcomes (8)
Plasma area under curve (AUC)(0-∞) of SPH3127
to evaluate Plasma AUC(0-∞) of SPH3127
Measured: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Change from baseline in laboratory hematology values
to evaluate the Change from baseline in laboratory hematology values
Measured: Baseline to 13-16 days post last dose
Change from baseline in laboratory chemistry values
to evaluate the Change from baseline in laboratory chemistry values
Measured: Baseline to 13-16 days post last dose
Change from baseline in laboratory urinalysis values
to evaluate the Change from baseline in laboratory urinalysis values
Measured: Baseline to 13-16 days post last dose
Change from baseline in ECG
to evaluate the Change from baseline in ECG
Measured: Baseline to 13-16 days post last dose
Maximum Plasma Concentration (Cmax) of SPH3127
to evaluate Plasma Cmax of SPH3127
Measured: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Plasma Maximum time to peak (Tmax) of SPH3127
to evaluate Plasma Tmax of SPH3127
Measured: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Apparent terminal half-life of SPH3127
to evaluate terminal half-life of SPH3127
Measured: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start23 Oct 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255993
- Sponsor's protocol ID
- SPH3127-102
- Status last verified
- Nov 2021
- First submitted
- 8 Aug 2017
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jing S, Xu R, Yang K, Liu W, Zhang L, Ke Y, Xia G, Lin Y. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Clin Ther. 2021 Apr;43(4):735.e1-735.e14. doi: 10.1016/j.clinthera.2021.01.025. Epub 2021 Feb 27.
PubMed 33653620
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People
- ClinicalTrials.gov ID
- NCT03255993
- Acronym / sponsor ID
- SPH3127-102
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 21 Aug 2017 (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 study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing
Detailed description
Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SPH3127 100mg | Experimental | Drug: SPH3127 50mgA single dose of SPH3127 50 mg*2 qd *7 days |
| Placebo to SPH3127 100mg | Placebo comparator | Drug: Placebo matching to SPH3127 50mgA single dose of placebo matching to SPH3127 50mg*2 qd *7 days |
| SPH3127 200mg | Experimental | Drug: SPH3127 100mgA single dose of SPH3127 100 mg*2 qd *7 days |
| Placebo to SPH3127 200mg | Placebo comparator | Drug: Placebo matching to SPH3127 100mgA single dose of placebo matching to SPH3127 100mg*2 qd *7 days |
| SPH3127 400mg | Experimental | Drug: SPH3127 100mgA single dose of SPH3127 100 mg*4 qd *7 days |
| Placebo to SPH3127 400mg | Placebo comparator | Drug: Placebo matching to SPH3127 100mgA single dose of placebo matching to SPH3127 100mg*4 qd *7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The body mass index is 18-28kg/m2 (including the critical value), which allows the minimum weight of men to be 50kg (including the critical value) and 45kg for women (including the critical value).
- Before the study,participant has know about the significance , potential benefits, inconveniences and potential risks of the study
- Participant has understood the research's procedure and sign the informed consent .
Key exclusion criteria (11 listed)
- Participant who are Pregnancy, lactating women, and planned trials begin within six months of pregnancy
- Participant who has abnormal Physical examination, laboratory examination results and clinical significance (such as: liver function examination - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of the upper limit of normal)
- Participant who has a history of cardiovascular, liver, kidney, digestive tract, nervous system, blood system, familial hematologic disease, abnormal thyroid function, or mental abnormality
- Participant who has drug allergy history and anaphylactic reaction
- Participant who took oral contraceptive in 6 months
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 |
|---|---|---|
| SPH3127 50mgAlso: SPH3127 is a new study drug for hypertensionSPH3127 50mg | Drug | SPH3127 100mg |
| SPH3127 100mgAlso: SPH3127 is a new study drug for hypertensionSPH3127 100mg | Drug | SPH3127 200mg, SPH3127 400mg |
| Placebo matching to SPH3127 50mgAlso: Placebo is oral tablet to matching to SPH3127 50mgPlacebo matching to SPH3127 50mg | Drug | Placebo to SPH3127 100mg |
| Placebo matching to SPH3127 100mgAlso: Placebo is oral tablet to matching to SPH3127 50mgPlacebo matching to SPH3127 100mg | Drug | Placebo to SPH3127 200mg, Placebo to SPH3127 400mg |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Baseline to 13-16 days post last dose
to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127
8 secondary outcomes
Plasma area under curve (AUC)(0-∞) of SPH3127
Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Change from baseline in laboratory hematology values
Time frame: Baseline to 13-16 days post last dose
Change from baseline in laboratory chemistry values
Time frame: Baseline to 13-16 days post last dose
Change from baseline in laboratory urinalysis values
Time frame: Baseline to 13-16 days post last dose
Change from baseline in ECG
Time frame: Baseline to 13-16 days post last dose
Maximum Plasma Concentration (Cmax) of SPH3127
Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Plasma Maximum time to peak (Tmax) of SPH3127
Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
Apparent terminal half-life of SPH3127
Time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
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 15 Nov 2021.
- Derived from this study: PubMed 33653620Jing S, Xu R, Yang K, Liu W, Zhang L, Ke Y, Xia G, Lin Y. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Clin Ther. 2021 Apr;43(4):735.e1-735.e14. doi: 10.1016/j.clinthera.2021.01.025. Epub 2021 Feb 27.
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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.
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 SPH3127 50mg and SPH3127 100mg in people with Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
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 3 inclusion and 11 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 15 Nov 2021. 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 China. 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?
Number of participants with adverse events (AEs) (time frame: Baseline to 13-16 days post last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255993, which also lists 1 linked publication.
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 15 Nov 2021.