SepsisPhase 1NCT04217629

Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 （Recombinant Human Annexin A5）in Healthy Subjects

A Phase 1 study testing SY-005 in people with Sepsis, run by Suzhou Yabao Pharmaceutical R&D 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

This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sepsis
What is being tested?: SY-005
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteChina
Study dates: 26 Apr 2019to 19 Aug 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults aged 18-65 (including two values);
During the screening period, the body weight of male subjects is greater than or equal to 50kg, and that of female subjects is greater than or equal to 45kg, with a body mass index (BMI = weight/height squared (kg/m2)) in the range of 18 to 26 (including both ends);
Medical history, physical examination, other laboratory examination items and examination related to the test before the test. All the tests were normal or not clinically significant mild abnormalities, clinical research doctors judged that qualified;
APTT and PT laboratory test results in coagulation function are within the normal range;
Platelet laboratory examination results are not lower than the lower limit of normal range；
The venous channel is normal and blood samples can be fully collected according to the plan;
Subjects must give informed consent to this study before the study and voluntarily sign a written informed consent;
Subjects are willing to take effective contraceptive measures, and have pregnancy plane during and within 3 months after the stud. Female subjects should be non-lactating, have negative pregnancy test, or have no fertility potential. Women who have been without a uterus for at least 12 months or are considered to have no potential pregnancy.

Who cannot join

The subjects are suffering from cardiovascular diseases, respiratory diseases, gastrointestinal diseases, liver and kidney function damage, endocrine diseases, blood system diseases, nervous system diseases, which can significantly change the distribution, metabolism and excretion of test drugs, or the use of test drugs will increase the risk of subjects or affect the analysis of research results;
QTc interval is not in normal range, male higher than 450 msec and female higher than 470 msec;
Those who have a history of drug or other allergies, or may be allergic to the study drug or any component of the study drug in the judgment of the researcher;
Those who completed or withdrawed from a clinical study within 3 months of the screening period, or is currently conducting a clinical study. Or participated in other medical research activities, which the researchers judged unsuitable for this study;
Have a history of alcohol abuse and drug abuse;
Those who have donated blood within 3 months, or those who plan to donate blood within 3 months, or those who have transfused blood within 4 weeks before the study;

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Women who consume more than 14 g of alcohol a week and men who consume more than 21 g of alcohol (1 g of alcohol is equivalent to360 mL of beer, 150 mL of wine or 45 mL of liquor) a week;Participants were reluctant to stop drinking between 24 hours before the study began and the end of the study;
Those who smoke more than 5 cigarettes a day or are unwilling/unable to stop nicotine intake during the study period;
Abnormal chest X-ray examination with clinical significance;
12-lead ecg showed clinically significant abnormalities, and the researcher believed that participating in the experiment would increase the risk of subjects;
Viral serological evidence during screening: patients with positive hepatitis B surface antigen (HBsAg), positive anti-hcv, or positive anti-HIV antibodyof human immunodeficiency virus (HIV), or positive anti-tp antibody of treponema pallidum;
Patients who have undergone major surgery within 6 months before drug administration;
Those who have been screened for the first 4 weeks or plan to receive live vaccines during the trial;
Fertile eligible subjects (male and female) will not agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study period and at least 1 months after administration;
The sponsor or the investigator decides that the investigator is not suitable to participate in the study; Women who have been without a uterus for at least 12 months or are considered to have no potential pregnancy.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Province Hospital
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-005 After Single-dose/Multiple-doses Incremental Intravenous Injection in Healthy Subjects

This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic study of a single-dose/multiple-doses incremental intravenous injection of SY-005（recombinant human annexin A5） in healthy subjects. Six sigle-dose group trials are planned: 0.75mg, 2.5mg, 5mg, 10mg, 15mg,and 20mg and three multiple-doses groups are planned: 5mg, 10mg and 20mg. Single-dose groups are planned to enroll 64 subjects and multiple-doses groups are planned to enroll 30 subjects.

Conditions: Sepsis
Being tested: SY-005
Medical subject headings: Sepsis

What participants receive

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

SY-005Drug
This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups.

Study groups in NCT04217629
Study group	Role	What they receive
SY-005 single-dose 0.75mg	Experimental	4 subjects will be envolved in this group and be injected with 0.75mg of SY-005. Receives: Drug: SY-005
SY-005 single-dose 2.5mg	Placebo comparator	This group will be intiated in healthy subjects at a 2.5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. Receives: Drug: SY-005
SY-005 single-dose 5mg	Placebo comparator	This group will be intiated in healthy subjects at a 5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. Receives: Drug: SY-005
SY-005 single-dose 10mg	Placebo comparator	This group will be intiated in healthy subjects at a 10mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. Receives: Drug: SY-005
SY-005 single-dose 15mg	Placebo comparator	This group will be intiated in healthy subjects at a 15mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. Receives: Drug: SY-005
SY-005 single-dose 20mg	Placebo comparator	This group will be intiated in healthy subjects at a 20mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1. Receives: Drug: SY-005
SY-005 multiple-doses 5mg	Placebo comparator	This group will be intiated in healthy subjects at a 5mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. Receives: Drug: SY-005
SY-005 multiple-doses 10mg	Placebo comparator	This group will be intiated in healthy subjects at a 10mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. Receives: Drug: SY-005
SY-005 multiple-doses 20mg	Placebo comparator	This group will be intiated in healthy subjects at a 20mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days. Receives: Drug: SY-005

What is being measured

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

Incidence of adverse events of SY-005
Incidence of adverse events of SY-005, collecting number of subjects with adverse events as assessed by CTCAE V5.0. Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal laboratory values, abnormal vital signs, abnormal physical examination, abnormal ECG data.
Measured: Single-dose: 21 days/ Multiple-doses: 28 days

Secondary outcomes (4)

Area under curve (AUC) of SY-005 following injection of single dose/multiple-doses
To mearsure the study drug concentration in blood samples which collected after injection
Measured: Single-dose: 24 hours/ Multiple-doses: 8 days
Cmax of SY-005 following injection of single dose/multiple-doses
To mearsure the study drug concentration in blood samples which collected after injection
Measured: Single-dose: 24 hours/ Multiple-doses: 8 days
Tmax of SY-005 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: Single-dose: 24 hours/ Multiple-doses: 8 days
T1/2 of SY-005 following injection of single dose
To mearsure the study drug concentration in blood samples which collected after injection
Measured: Single-dose: 24 hours/ Multiple-doses: 8 days

Timeline

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

26 Apr 201919 Aug 2020

First posted3 Jan 2020
Study start26 Apr 2019
Primary completion5 Oct 2019
Study completion19 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SepsisStudies of the same condition, open and under way.
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: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04217629
Sponsor's protocol ID: SY005001
Status last verified: Apr 2021
First submitted: 1 Jan 2020
Last updated: 3 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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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Sepsis

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-005 After Single-dose/Multiple-doses Incremental Intravenous Injection in Healthy Subjects
ClinicalTrials.gov ID: NCT04217629
Acronym / sponsor ID: SY005001
Conditions: Sepsis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Apr 2019 (actual)
Primary completion: 5 Oct 2019 (actual)
Study completion: 19 Aug 2020 (actual)
First posted: 3 Jan 2020 (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 is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

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: 9

Arm	Type	Receives
SY-005 single-dose 0.75mg	Experimental	Drug: SY-0054 subjects will be envolved in this group and be injected with 0.75mg of SY-005.
SY-005 single-dose 2.5mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 2.5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1.
SY-005 single-dose 5mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 5mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1.
SY-005 single-dose 10mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 10mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1.
SY-005 single-dose 15mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 15mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1.
SY-005 single-dose 20mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 20mg dose. 12 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 5:1.
SY-005 multiple-doses 5mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 5mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days.
SY-005 multiple-doses 10mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 10mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days.
SY-005 multiple-doses 20mg	Placebo comparator	Drug: SY-005This group will be intiated in healthy subjects at a 20mg dose. 10 subjects will be envolved in this group and the proportion of subjects injected SY-005 to placebo is 4:1. The subjects will be injected with SY-005 or placebo for 7days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy adults aged 18-65 (including two values);
During the screening period, the body weight of male subjects is greater than or equal to 50kg, and that of female subjects is greater than or equal to 45kg, with a body mass index (BMI = weight/height squared (kg/m2)) in the range of 18 to 26 (including both ends);
Medical history, physical examination, other laboratory examination items and examination related to the test before the test. All the tests were normal or not clinically significant mild abnormalities, clinical research doctors judged that qualified;
APTT and PT laboratory test results in coagulation function are within the normal range;
Platelet laboratory examination results are not lower than the lower limit of normal range；

Key exclusion criteria (15 listed)

The subjects are suffering from cardiovascular diseases, respiratory diseases, gastrointestinal diseases, liver and kidney function damage, endocrine diseases, blood system diseases, nervous system diseases, which can significantly change the distribution, metabolism and excretion of test drugs, or the use of test drugs will increase the risk of subjects or affect the analysis of research results;
QTc interval is not in normal range, male higher than 450 msec and female higher than 470 msec;
Those who have a history of drug or other allergies, or may be allergic to the study drug or any component of the study drug in the judgment of the researcher;
Those who completed or withdrawed from a clinical study within 3 months of the screening period, or is currently conducting a clinical study. Or participated in other medical research activities, which the researchers judged unsuitable for this study;
Have a history of alcohol abuse and drug abuse;

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
SY-005This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups.	Drug	SY-005 multiple-doses 10mg, SY-005 multiple-doses 20mg, SY-005 multiple-doses 5mg, SY-005 single-dose 0.75mg, SY-005 single-dose 10mg, SY-005 single-dose 15mg, SY-005 single-dose 2.5mg, SY-005 single-dose 20mg, SY-005 single-dose 5mg

Primary outcome

Incidence of adverse events of SY-005
Time frame: Single-dose: 21 days/ Multiple-doses: 28 days
Incidence of adverse events of SY-005, collecting number of subjects with adverse events as assessed by CTCAE V5.0. Number of subjects with adverse events, major adverse events, serious adverse events, pregnancy events, abnormal laboratory values, abnormal vital signs, abnormal physical examination, abnormal ECG data.

4 secondary outcomes

Area under curve (AUC) of SY-005 following injection of single dose/multiple-doses
Time frame: Single-dose: 24 hours/ Multiple-doses: 8 days
Cmax of SY-005 following injection of single dose/multiple-doses
Time frame: Single-dose: 24 hours/ Multiple-doses: 8 days
Tmax of SY-005 following injection of single dose
Time frame: Single-dose: 24 hours/ Multiple-doses: 8 days
T1/2 of SY-005 following injection of single dose
Time frame: Single-dose: 24 hours/ Multiple-doses: 8 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 3 Jun 2021.
Individual participant dataSharing planned: Undecided

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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 SY-005 in people with Sepsis, run by Suzhou Yabao Pharmaceutical R&D 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 8 inclusion and 15 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 3 Jun 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?

Incidence of adverse events of SY-005 (time frame: Single-dose: 21 days/ Multiple-doses: 28 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 NCT04217629.

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 3 Jun 2021.