HypertensionPhase 1NCT03128138

Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers

A Phase 1 study testing SPH3127 in people with Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers. 2. To explore the appropriate dose and provide the basis for the subsequent clinical trials. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 1 Dec 2016to 30 Jul 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

Healthy adults,age >=18 years.Single gender should no less than a third of total subjects in each group.
BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female.
understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent.

Who cannot join

during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant;
abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal).
with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness;
has a history of drug allergy and allergic constitution;
took birth control pills within 6 weeks;
used any drugs (including Chinese herbal medicine) within 1 week;

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participated in blood donation within 2 months ;
participated in any drug clinical trials (as subjects) within three months;
any positive result in virus serology check: human immunodeficiency virus antigen antibody (HIV Ag/Ab) 、hepatitis c virus (HCV) - IgG antibody to IgG, hepatitis b surface antigen (HBsAg) and treponema pallidum antibody (TP);
addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse;
researchers think that exists any unfavorable factors to participate in the test.

Trial locations and contacts

1 site in 1 country.

China1 site

The capital medical university affiliated Beijing anzhen hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers

To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers.
To explore the appropriate dose and provide the basis for the subsequent clinical trials.

Read the detailed description

48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.

Conditions: Hypertension
Being tested: SPH3127
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SPH3127Drug
Drug: SPH3127 Tablet
Drug: Placebo Tablet

Study groups in NCT03128138
Study group	Role	What they receive
25 mg SPH3127 tablet-Dose 1	Experimental	6 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet. Receives: Drug: SPH3127
50 mg SPH3127 tablet-Dose 2	Experimental	6 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet. Receives: Drug: SPH3127
100 mg SPH3127 tablet-Dose 3	Experimental	6 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet. Receives: Drug: SPH3127
200 mg SPH3127 tablet-Dose 4	Experimental	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet. Receives: Drug: SPH3127
400 mg SPH3127 tablet-Dose 5	Experimental	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet. Receives: Drug: SPH3127
800 mg SPH3127 tablet-Dose 6	Experimental	6 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet. Receives: Drug: SPH3127

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
adverse events, laboratory data, vital signs, and ECG et al.
Measured: 10 days

Secondary outcomes (5)

Assessment of PK parameter 1 [Cmax]
Peak plasma concentration (Cmax)
Measured: 2 days
Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]
Inhibition of Renion Activity (%)
Measured: 2 days
Assessment of PD parameter 2 [Blood pressure (mmHg)]
Blood pressure (mmHg)
Measured: 2 days
Assessment of PK parameter 2 [tmax]
time to peak plasma concentration (tmax)
Measured: 2 days
Assessment of PK parameter 3 [AUC]
Area under the plasma concentration versus time curve (AUC)
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201630 Jul 2018

First posted25 Apr 2017
Study start1 Dec 2016
Primary completion30 Jun 2018
Study completion30 Jul 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03128138
Sponsor's protocol ID: SPH3127-101
Status last verified: Nov 2021
First submitted: 5 Jan 2017
Last updated: 27 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT03128138
Acronym / sponsor ID: SPH3127-101
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
Study start: 1 Dec 2016 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 30 Jul 2018 (actual)
First posted: 25 Apr 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.

To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers.
To explore the appropriate dose and provide the basis for the subsequent clinical trials.

Detailed description

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
25 mg SPH3127 tablet-Dose 1	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet, 25mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 25mg, po. 1 tablet.
50 mg SPH3127 tablet-Dose 2	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet, 50mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 50mg, po. 1 tablet.
100 mg SPH3127 tablet-Dose 3	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet, 100mg, po. 1 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 1 tablet.
200 mg SPH3127 tablet-Dose 4	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet,100mg, po. 2 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 2 tablet.
400 mg SPH3127 tablet-Dose 5	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet,100mg, po. 4 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 4 tablet.
800 mg SPH3127 tablet-Dose 6	Experimental	Drug: SPH31276 Volunteers, Single dose of SPH3127 tablet,100mg, po. 8 tablet. 2 Volunteers, Single dose of Placebo tablet, 100mg, po. 8 tablet.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy adults,age >=18 years.Single gender should no less than a third of total subjects in each group.
BMI should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female.
understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent.

Key exclusion criteria (11 listed)

during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant;
abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (AST)/alanine aminotransferase (ALT) is more than 1.5 times of the upper limit of normal).
with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness;
has a history of drug allergy and allergic constitution;
took birth control pills within 6 weeks;

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
SPH3127Drug: SPH3127 Tablet Drug: Placebo Tablet	Drug	100 mg SPH3127 tablet-Dose 3, 200 mg SPH3127 tablet-Dose 4, 25 mg SPH3127 tablet-Dose 1, 400 mg SPH3127 tablet-Dose 5, 50 mg SPH3127 tablet-Dose 2, 800 mg SPH3127 tablet-Dose 6

Primary outcome

Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG]
Time frame: 10 days
adverse events, laboratory data, vital signs, and ECG et al.

5 secondary outcomes

Assessment of PK parameter 1 [Cmax]
Time frame: 2 days
Assessment of PD parameter 1 [Inhibition of Renion Activity (%)]
Time frame: 2 days
Assessment of PD parameter 2 [Blood pressure (mmHg)]
Time frame: 2 days
Assessment of PK parameter 2 [tmax]
Time frame: 2 days
Assessment of PK parameter 3 [AUC]
Time frame: 2 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 27 Oct 2022.
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.
Individual participant dataSharing planned: No

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

HONG MIAO principal investigator

Shanghai Pharmaceuticals Holding 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 SPH3127 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 27 Oct 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 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. 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?

Assessment of safety parameters [adverse events, laboratory data, vital signs, and ECG] (time frame: 10 days). 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 NCT03128138, 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 27 Oct 2022.