Diabetic Neuropathy PeripheralPhase 1NCT03988413

Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

A Phase 1 study testing 25mg, 50mg and 100mg in people with Diabetic Neuropathy Peripheral, run by CSPC ZhongQi Pharmaceutical Technology 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

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Diabetic Neuropathy Peripheral
What is being tested?: 25mg, 50mg and 100mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteChina
Study dates: 5 Aug 2019to 14 Jan 2020
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

18≤Age≤45, male or female;
Body weight (> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (< BMI) = 26.0 kg/m2);
Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

Who cannot join

Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;
Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;
Surgery history within six months before signing the informed consent;
Allergic history to more than one drug or other serious allergic rhistory.
Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;
Positive with serum immunological test for HBsAg, Anti-HCV, Anti-HIV or Anti-TP;

Show all 10Show fewer

History of drugs or drug abuse or alcoholics;
History of blood donation more than 200 mL within 8 weeks before signing informed consent;
Subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent;
Not suitable for this trial according to the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

The General Hospital of the People's Liberation Army
Beijing

Other trials in China

About this study

Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Conditions: Diabetic Neuropathy Peripheral
Being tested: 25mg, 50mg, 100mg, 200mg, 400mg

What participants receive

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

25mgDrug
SYHA1402 25mg or Placebo 25mg
50mgDrug
SYHA1402 50mg or Placebo 50mg
100mgDrug
SYHA1402 100mg or Placebo 100mg
200mgDrug
SYHA1402 200mg or Placebo 200mg
400mgDrug
SYHA1402 400mg or Placebo 400mg
800mgDrug
SYHA1402 800mg or Placebo 800mg

Study groups in NCT03988413
Study group	Role	What they receive
25mg	Experimental	Tablets, Oral, 25mg, single dose Receives: Drug: 25mg
50mg	Experimental	Tablets, Oral, 50mg, single dose Receives: Drug: 50mg
100mg	Experimental	Tablets, Oral, 100mg, single dose Receives: Drug: 100mg
200mg	Experimental	Tablets, Oral, 200mg, single dose Receives: Drug: 200mg
400mg	Experimental	Tablets, Oral, 400mg, single dose Receives: Drug: 400mg
800mg	Experimental	Tablets, Oral, 800mg, single dose Receives: Drug: 800mg

What is being measured

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

Change of systolic blood pressure and diastolic blood pressure
To assess the change of blood pressure after administration of SYHA1402
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of heart rate
To assess the change of heart rate after administration of SYHA1402
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of pulse
To assess pulse after administration of SYHA1402
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of body temperature
To assess the change of body temperature after administration of SYHA1402
Measured: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
Change of 12-lead ECG
To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402
Measured: 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
Change of physical examination
To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402
Measured: 24, 48, 72 hours
Change of blood biochemistry
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Measured: 24, 48, 72 hours
Chagne of blood routine
To assess the change of blood routine after administration of SYHA1402
Measured: 24, 48, 72 hours
Change of urinary routine
To assess the change of urinary routine after administration of SYHA1402
Measured: 24, 48, 72 hours

Secondary outcomes (6)

Peak concentration (Cmax)
Plasma peak concentration (Cmax) after administration of SYHA1402
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Peak time (Tmax)
Plasma peak time (Tmax) after administration of SYHA1402
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Area under the plasma concentration-time curve (AUC0-72h)
The area under the plasma concentration-time curve of SYHA1402 after administration are calculated.
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Half time (t1/2)
The half time of SYHA1402 after administration are calculated.
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Apparent clearance (CL/F)
To assess the apparent clearance (CL/F) after administration of SYHA1402
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
To assess the Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
Measured: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours

Timeline

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

5 Aug 201914 Jan 2020

First posted17 Jun 2019
Study start5 Aug 2019
Primary completion14 Jan 2020
Study completion14 Jan 2020

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 Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
More trials run by CSPC ZhongQi Pharmaceutical Technology 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: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03988413
Sponsor's protocol ID: SYHA1402201801/PRO-1
Status last verified: Jun 2019
First submitted: 10 Jun 2019
Last updated: 30 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Liang B, Wang J, Zhang G, Wang R, Cai Y. Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects. Neurol Ther. 2023 Jun;12(3):947-959. doi: 10.1007/s40120-023-00480-x. Epub 2023 Apr 24.
PubMed 37093466

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?

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All Diabetic Neuropathy Peripheral trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects
ClinicalTrials.gov ID: NCT03988413
Acronym / sponsor ID: SYHA1402201801/PRO-1
Conditions: Diabetic Neuropathy Peripheral
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 5 Aug 2019 (actual)
Primary completion: 14 Jan 2020 (actual)
Study completion: 14 Jan 2020 (actual)
First posted: 17 Jun 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.

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

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
25mg	Experimental	Drug: 25mgTablets, Oral, 25mg, single dose
50mg	Experimental	Drug: 50mgTablets, Oral, 50mg, single dose
100mg	Experimental	Drug: 100mgTablets, Oral, 100mg, single dose
200mg	Experimental	Drug: 200mgTablets, Oral, 200mg, single dose
400mg	Experimental	Drug: 400mgTablets, Oral, 400mg, single dose
800mg	Experimental	Drug: 800mgTablets, Oral, 800mg, single dose

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

18≤Age≤45, male or female;
Body weight (> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (< BMI) = 26.0 kg/m2);
Subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination;
All subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study;
Subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal.

Key exclusion criteria (10 listed)

Female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm;
Have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history;
Surgery history within six months before signing the informed consent;
Allergic history to more than one drug or other serious allergic rhistory.
Subjects with a QTc interval greater than 450 ms (male) or 470 MS (female), or with a history of prolonged QTc interval;

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
25mgSYHA1402 25mg or Placebo 25mg	Drug	25mg
50mgSYHA1402 50mg or Placebo 50mg	Drug	50mg
100mgSYHA1402 100mg or Placebo 100mg	Drug	100mg
200mgSYHA1402 200mg or Placebo 200mg	Drug	200mg
400mgSYHA1402 400mg or Placebo 400mg	Drug	400mg
800mgSYHA1402 800mg or Placebo 800mg	Drug	800mg

Primary outcome

Change of systolic blood pressure and diastolic blood pressure
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of blood pressure after administration of SYHA1402
Change of heart rate
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of heart rate after administration of SYHA1402
Change of pulse
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess pulse after administration of SYHA1402
Change of body temperature
Time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours
To assess the change of body temperature after administration of SYHA1402
Change of 12-lead ECG
Time frame: 0, 0.5, 1, 2, 4, 8, 24, 48, 72 hours
To assess the change of 12-lead ECG (PR，QRS，QT，QTc) after administration of SYHA1402
Change of physical examination
Time frame: 24, 48, 72 hours
To assess the change of physical examination (including cardiovascular system, chest and lung, abdomen, nervous system, skeletal muscle system, etc) after administration of SYHA1402
Change of blood biochemistry
Time frame: 24, 48, 72 hours
To assess the change of blood biochemistry (including LDL, HDL,TC, ALT, AST, etc) after administration of SYHA1402
Chagne of blood routine
Time frame: 24, 48, 72 hours
To assess the change of blood routine after administration of SYHA1402
Change of urinary routine
Time frame: 24, 48, 72 hours
To assess the change of urinary routine after administration of SYHA1402

6 secondary outcomes

Peak concentration (Cmax)
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Peak time (Tmax)
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Area under the plasma concentration-time curve (AUC0-72h)
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Half time (t1/2)
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Apparent clearance (CL/F)
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours
Proportional dose-response relationship between pharmacokinetic parameters Cmax and AUC of SYHA1402
Time frame: 10minutes, 20minutes, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours

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 30 Apr 2020.
Derived from this study: PubMed 37093466Liang B, Wang J, Zhang G, Wang R, Cai Y. Safety, Tolerability and Pharmacokinetics of Single-Dose Oral SYHA1402 in Healthy Chinese Subjects. Neurol Ther. 2023 Jun;12(3):947-959. doi: 10.1007/s40120-023-00480-x. Epub 2023 Apr 24.
Individual participant dataSharing planned: No

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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 25mg, 50mg and 100mg in people with Diabetic Neuropathy Peripheral, run by CSPC ZhongQi Pharmaceutical Technology 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 5 inclusion and 10 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 30 Apr 2020. 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?

Change of systolic blood pressure and diastolic blood pressure (time frame: 0, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 hours). The study lists 9 primary outcomes in all. 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 NCT03988413, 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 30 Apr 2020.