Overweight or ObesityPhase 1NCT06830343
The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity
A Phase 1 study testing SYH9017 and Wegovy ® in people with Overweight or Obesity, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- SYH9017 and Wegovy ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;
- SAD phase: Body Mass Index (BMI) = weight (kg)/height^2 , with BMI in the range of 24.0-28.0 kg/m^2 (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)/height^2 , with BMI ≥28.0 kg/m^2;
- Weight change <5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) / weight at screening * 100%;
- Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;
- Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible adverse reactions, voluntarily sign the informed consent form before the trial, and ensure that they will personally participate in any procedures; Participants and their partners agree to use effective non-hormonal contraception methods (such as condoms, inert intrauterine devices, female barrier methods [cervical cap or diaphragm with spermicide], vaginal contraceptive rings, etc.) from the time of signing the informed consent form until 6 months after the last dose, or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); Male participants do not plan to donate sperm from the time of signing the informed consent form until 6 months after the last dose, and female participants do not plan to donate eggs from the time of signing the informed consent form until 6 months after the last dose.
Who cannot join
- A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational drug;
- A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system, hematological system, central nervous system, or other conditions that may endanger the safety of participants or affect the absorption, metabolism, or excretion of the study drug, and are deemed unsuitable for inclusion by the investigator;
- A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as depression, schizophrenia, bipolar disorder, or a history of suicidal ideation or behavior), epilepsy, acute biliary disease, or confirmed acute or chronic pancreatitis; participants judged by the investigator to be unsuitable for participation in this clinical study;
- Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of glucagonoma or pheochromocytoma, or other endocrine diseases that may affect glucose metabolism, or has experienced ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia;
- A personal or family history of medullary thyroid carcinoma (MTC) or a history of multiple endocrine neoplasia type 2 (MEN2).
- Any one of the following criteria is met:
Show all 21Show fewer
- Participants with one or more abnormal vital signs: body temperature <35.5°C or >37.2°C, pulse rate <50 beats per minute or >100 beats per minute, systolic blood pressure ≥160 mmHg or <90 mmHg, diastolic blood pressure ≥100 mmHg or <60 mmHg. A single retest is allowed, and participants with abnormalities in both tests will be excluded; ii. Any of the following laboratory abnormalities: a) Fasting plasma glucose ≥7.0 mmol/L or fasting plasma glucose <3.9 mmol/L or HbA1c level >6.5%; b) AST or ALT >2 times the upper limit of normal (ULN), total bilirubin >1.5 times ULN, deemed clinically significant by the investigator; c) Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m²; d) Serum amylase or lipase >3 times ULN; e) Blood low-density lipoprotein cholesterol (LDL-C) ≥4.40 mmol/L; f) Triglycerides (TG) ≥5.65 mmol/L.
- During the multiple-dose phase: Use of any approved or unapproved drugs or products that may affect body weight within 6 months prior to screening, including but not limited to orlistat, phentermine-topiramate, naltrexone-bupropion, systemic steroid medications (administered intravenously, orally, or intra-articularly), antidepressants (selective serotonin reuptake inhibitors (SSRIs), noradrenaline reuptake inhibitors (SNRIs), tricyclics, tetracyclics, etc.), psychotropic medications or sedative drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproate, valproate derivatives, lithium salts), etc.; or use of traditional Chinese medicines, health supplements, meal replacements, or antibiotic drugs or probiotic preparations that influence gut microbiota and thereby affect body weight; or having undergone bariatric surgery within 6 months prior to screening;
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 analogs (such as liraglutide, dulaglutide, lixisenatide, exenatide, albiglutide, benraliptide, polyethylene glycol loxenatide, etc.) or any dipeptidyl peptidase-4 (DPP-4) inhibitors or glucose-dependent insulinotropic polypeptide (GIP) receptor agonists within 6 months prior to signing the informed consent form.
- Use of any prescription medications, over-the-counter medications, traditional Chinese patent medicines, herbal remedies, vitamin dietary supplements, or health products within 4 weeks prior to signing the informed consent form;
- Habitual intake of or consumption of excessive amounts of xanthine or caffeine-containing foods, beverages, or other substances that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening or within 72 hours before using the investigational drug. Examples include: coffee (more than 1100 mL per day), tea (more than 2200 mL per day), cola (more than 2200 mL per day), energy drinks (more than 1100 mL per day), chocolate (more than 510 g per day);
- Undergone surgery (including cosmetic, dental, and oral surgeries) within 6 months prior to screening or planned during the trial period, or plans to engage in vigorous physical activity (including contact sports or collision sports) during the trial period;
- A history of drug abuse or a positive drug screening test within 1 year prior to signing the informed consent form;
- Loss of blood or donation of more than 400 mL of blood within 3 months prior to signing the informed consent form, or receipt of blood transfusions or use of blood products;
- Consumption of more than 14 units of alcohol per week (1 unit = 285 mL of beer; 25 mL of spirits; 150 mL of wine) within 3 months prior to signing the informed consent form, or consumption of any alcohol-containing products within 48 hours before using the investigational drug; positive baseline alcohol test (>0 mg/100 mL) or inability to abstain from alcohol during the trial period;
- Smoking ≥5 cigarettes daily within 6 months prior to signing the informed consent form, smoking within 48 hours before using the investigational drug, or inability to cease the use of any tobacco products during the trial period;
- Participation in any clinical trial involving investigational drugs or medical devices within 3 months prior to signing the informed consent form;
- Pregnant and/or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening and before dosing;
- A history of vasovagal syncope or hemophobia, or difficulty with venipuncture for any reason, making it intolerable;
- Difficulty with subcutaneous injection administration;
- Any other factors deemed by the investigator to make the participant unsuitable for participation in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Dongyang Liu, PhD, +86-010-82266456, liudongyang@vip.sina.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic of SYH9017 in Chinese Participants With Overweight and Obesity Following Single and Multiple Doses
This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.
- Conditions
- Overweight or Obesity
- Being tested
- SYH9017, Placebo, Wegovy ®
- Keywords
- overweight or obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH9017Drug
subcutaneous injection once time in SAD and four times in MAD
PlaceboDrug
subcutaneous injection once time in SAD and four times in MAD
Wegovy ®Drug
subcutaneous injection once a week
| Study group | Role | What they receive |
|---|---|---|
| SYH9017 SAD experimental group | Experimental | Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH9017 on Day 1 Receives: Drug: SYH9017 |
| Placebo SAD group | Placebo comparator | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1 Receives: Drug: Placebo |
| SYH9017 MAD experimental group | Experimental | Subjects in MAD experimental groups will receive subcutaneous injection of SYH9017 every 4weeks Receives: Drug: SYH9017 |
| Placebo MAD group | Placebo comparator | Subjects in MAD placebo groups will receive subcutaneous injection of placebo every 4weeks Receives: Drug: Placebo |
| Positive Control MAD group | Active comparator | Subjects in MAD active comparator groups will receive subcutaneous injection of placebo every weeks Receives: Drug: Wegovy ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs following single-dose administration of SYH9017 Description:
Measured: up to 49 days after the dosing
Incidence of AEs following multiple doses administration of SYH9017AEs of SYH 9017 following multiple doses
Measured: up to 140 days after the last dosing
Secondary outcomes (24)
The Cmax of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The AUC of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The Tmax of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The t1/2 of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The CL/F of SYH9017 following single-dose
Measured: *Time Frame:up to 49 days after the dosing
The Vz/F of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The proportion of patients (%) who developed binding antibodies and neutralizing antibodies following single-dose administration of SYH9017
Measured: up to 49 days after the dosing
The percentage change in body weight from baseline of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The percentage change in waist circumference from baseline of SYH9017 following single-dose
Measured: up to 49 days after the dosing
The Cmax of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The AUC of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The Tmax of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The t1/2 of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The CL/F of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The Vz/F of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The Cmin of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The RAUC of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The RCmax of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The proportion of patients (%) who developed binding antibodies and neutralizing antibodies following multiple doses administration of SYH9017
Measured: up to 140 days after the last dosing
The percentage change in body weight from baseline of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The percentage change in waist circumference from baseline of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The proportion of participants with ≥5% weight loss during the trial period of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The proportion of participants with ≥10% weight loss during the trial period of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
The changes in body composition (including visceral, peripheral fat, and skeletal muscle) as measured by body fat analyzer after 16 weeks of treatment, compared to baseline of SYH9017 following multiple doses
Measured: up to 140 days after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start27 Feb 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830343
- Sponsor's protocol ID
- SYH9017-001
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic of SYH9017 in Chinese Participants With Overweight and Obesity Following Single and Multiple Doses
- ClinicalTrials.gov ID
- NCT06830343
- Acronym / sponsor ID
- SYH9017-001
- Conditions
- Overweight or Obesity
- Keywords
- overweight or obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 17 Feb 2025 (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 randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| SYH9017 SAD experimental group | Experimental | Drug: SYH9017Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH9017 on Day 1 |
| Placebo SAD group | Placebo comparator | Drug: PlaceboSubjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1 |
| SYH9017 MAD experimental group | Experimental | Drug: SYH9017Subjects in MAD experimental groups will receive subcutaneous injection of SYH9017 every 4weeks |
| Placebo MAD group | Placebo comparator | Drug: PlaceboSubjects in MAD placebo groups will receive subcutaneous injection of placebo every 4weeks |
| Positive Control MAD group | Active comparator | Drug: Wegovy ®Subjects in MAD active comparator groups will receive subcutaneous injection of placebo every weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;
- SAD phase: Body Mass Index (BMI) = weight (kg)/height^2 , with BMI in the range of 24.0-28.0 kg/m^2 (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)/height^2 , with BMI ≥28.0 kg/m^2;
- Weight change <5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) / weight at screening * 100%;
- Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;
- Able to read and understand the written informed consent related to the study information, fully aware of the study content, process, and possible adverse reactions, voluntarily sign the informed consent form before the trial, and ensure that they will personally participate in any procedures; Participants and their partners agree to use effective non-hormonal contraception methods (such as condoms, inert intrauterine devices, female barrier methods [cervical cap or diaphragm with spermicide], vaginal contraceptive rings, etc.) from the time of signing the informed consent form until 6 months after the last dose, or have already adopted permanent contraception measures (such as bilateral tubal ligation, vasectomy, etc.); Male participants do not plan to donate sperm from the time of signing the informed consent form until 6 months after the last dose, and female participants do not plan to donate eggs from the time of signing the informed consent form until 6 months after the last dose.
Key exclusion criteria (21 listed)
- A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational drug;
- A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system, hematological system, central nervous system, or other conditions that may endanger the safety of participants or affect the absorption, metabolism, or excretion of the study drug, and are deemed unsuitable for inclusion by the investigator;
- A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as depression, schizophrenia, bipolar disorder, or a history of suicidal ideation or behavior), epilepsy, acute biliary disease, or confirmed acute or chronic pancreatitis; participants judged by the investigator to be unsuitable for participation in this clinical study;
- Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of glucagonoma or pheochromocytoma, or other endocrine diseases that may affect glucose metabolism, or has experienced ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia;
- A personal or family history of medullary thyroid carcinoma (MTC) or a history of multiple endocrine neoplasia type 2 (MEN2).
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 |
|---|---|---|
| SYH9017subcutaneous injection once time in SAD and four times in MAD | Drug | SYH9017 MAD experimental group, SYH9017 SAD experimental group |
| Placebosubcutaneous injection once time in SAD and four times in MAD | Drug | Placebo MAD group, Placebo SAD group |
| Wegovy ®subcutaneous injection once a week | Drug | Positive Control MAD group |
Primary outcome
Incidence of AEs following single-dose administration of SYH9017 Description:
Time frame: up to 49 days after the dosing
Incidence of AEs following multiple doses administration of SYH9017AEs of SYH 9017 following multiple doses
Time frame: up to 140 days after the last dosing
24 secondary outcomes
The Cmax of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The AUC of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The Tmax of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The t1/2 of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The CL/F of SYH9017 following single-dose
Time frame: *Time Frame:up to 49 days after the dosing
The Vz/F of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The proportion of patients (%) who developed binding antibodies and neutralizing antibodies following single-dose administration of SYH9017
Time frame: up to 49 days after the dosing
The percentage change in body weight from baseline of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The percentage change in waist circumference from baseline of SYH9017 following single-dose
Time frame: up to 49 days after the dosing
The Cmax of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The AUC of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The Tmax of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The t1/2 of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The CL/F of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The Vz/F of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The Cmin of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The RAUC of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The RCmax of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The proportion of patients (%) who developed binding antibodies and neutralizing antibodies following multiple doses administration of SYH9017
Time frame: up to 140 days after the last dosing
The percentage change in body weight from baseline of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The percentage change in waist circumference from baseline of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The proportion of participants with ≥5% weight loss during the trial period of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The proportion of participants with ≥10% weight loss during the trial period of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
The changes in body composition (including visceral, peripheral fat, and skeletal muscle) as measured by body fat analyzer after 16 weeks of treatment, compared to baseline of SYH9017 following multiple doses
Time frame: up to 140 days after the last dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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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.
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 SYH9017 and Wegovy ® in people with Overweight or Obesity, run by CSPC Baike (Shandong) Biopharmaceutical 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 21 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer, / (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs following single-dose administration of SYH9017 Description: (time frame: up to 49 days after the dosing). The study lists 2 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 6 Apr 2026.