Neuropathy of DiabetesPhase 1NCT03791125
Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets
A Phase 1 study testing Salvianolic Acid A in people with Neuropathy of Diabetes, run by Peking University First Hospital at 1 site in China.
Trial summary
Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathy of Diabetes
- What is being tested?
- Salvianolic Acid A
- 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 siteChina
- Study dates
- 20 Nov 2018to 20 May 2019
- 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
- 1) Gender: male or female, healthy volunteers; 2) Age: 18~45 years old; 3) Weight: Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index [BMI = weight (kg) / height 2 (m2)] in the range of 19 ~ 25 kg / m2; 4) Subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
Who cannot join
- (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xiaocong Pang, Ph.D., 010-66110802, pangxiaocong1227@163.com
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers
Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica, Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate diabetic complications and improve patients' quality of life. With the support of major national science and technology projects, the preclinical research work of salvianolic acid A was completed, and the application was approved by the State Food and Drug Administration (Clinical Approval No.: 2016L06293). Peking University First Hospital was used as the research unit. This study is the first human clinical trial of the drug. The project leader of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.
- Conditions
- Neuropathy of Diabetes
- Being tested
- Salvianolic Acid A, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvianolic Acid ADrug
4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.
Placebo Oral TabletDrug
Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Salvianolic Acid A |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of treatment-emergent adverse events
Measured: 7 days
Percentage of participants with change from baseline in vital signs
Heart rate, Blood Pressure，auxillary temperature
Measured: 7 days
Change from baseline in electrocardiograms (ECGs)
PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Measured: 7 days
Percentage of participants with change from baseline in clinical laboratory parameters
blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
Measured: 7 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]
Measured: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
Measured: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start20 Nov 2018
- Primary completion20 Mar 2019 (estimated)
- Study completion20 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy of DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Huizhi Pharmaceutical Technology Co., Ltd., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Principal investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791125
- Sponsor's protocol ID
- 2018028
- Status last verified
- Dec 2018
- First submitted
- 15 Nov 2018
- Last updated
- 2 Jan 2019
- 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 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03791125
- Acronym / sponsor ID
- 2018028
- Conditions
- Neuropathy of Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Shandong Huizhi Pharmaceutical Technology Co., Ltd., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Mar 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 2 Jan 2019 (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.
Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica, Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate diabetic complications and improve patients' quality of life. With the support of major national science and technology projects, the preclinical research work of salvianolic acid A was completed, and the application was approved by the State Food and Drug Administration (Clinical Approval No.: 2016L06293). Peking University First Hospital was used as the research unit. This study is the first human clinical trial of the drug. The project leader of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Salvianolic Acid A |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Gender: male or female, healthy volunteers; 2) Age: 18~45 years old; 3) Weight: Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index [BMI = weight (kg) / height 2 (m2)] in the range of 19 ~ 25 kg / m2; 4) Subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
Key exclusion criteria (1 listed)
- (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
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 |
|---|---|---|
| Salvianolic Acid A4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study. | Drug | Experimental |
| Placebo Oral TabletPlacebo tablets containing no salvianolic acid A will be given to healthy subjects. | Drug | Placebo |
Primary outcome
Subject incidence of treatment-emergent adverse events
Time frame: 7 days
Percentage of participants with change from baseline in vital signs
Time frame: 7 days
Heart rate, Blood Pressure，auxillary temperature
Change from baseline in electrocardiograms (ECGs)
Time frame: 7 days
PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Percentage of participants with change from baseline in clinical laboratory parameters
Time frame: 7 days
blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]
Time frame: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
Time frame: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
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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.
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 Salvianolic Acid A in people with Neuropathy of Diabetes, run by Peking University First Hospital 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 1 inclusion and 1 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 2 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaocong Pang, Ph.D. (010-66110802, pangxiaocong1227@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of treatment-emergent adverse events (time frame: 7 days). The study lists 7 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 2 Jan 2019.