Healthy ParticipantsPhase 1NCT07412353
A Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2085
A Phase 1 study testing SYH2085 in people with Healthy Participants, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- SYH2085
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 31 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 - 45 years (inclusive), male or female; BMI: 19.0-28.0 kg/m^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female;
- Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
- Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 3 months after the end of the study;
- Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.
Who cannot join
- History of hypersensitivity or allergy to drug or food, or any component of the study drug；
- Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug;
- History of gastrointestinal surgery or resection that may alter the absorption and/or elimination of orally administered drugs (except for appendectomy);
- Participants who have undergone any surgical procedure within 6 months prior to the trial;
- Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening;
- Participants who have experienced blood loss exceeding 400 mL (e.g., due to blood donation or other reasons) within 3 months prior to the trial;
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- Participants who have participated in another investigational drug study within 3 months prior to the planned administration of the study drug, where the last dose was received less than 3 months before screening for this trial; or subjects who plan to participate in another drug trial during the course of this study;
- Participants who have been vaccinated within 28 days prior to screening or plan to receive vaccination during the trial period;
- Participants who have taken any prescription drugs, over-the-counter (OTC) medications, Chinese patent medicines, herbal medicines, health supplements, or oral supplements (e.g., calcium, iron, magnesium, selenium, zinc, etc.) within 28 days prior to screening or during the trial period;
- Participants who have used oral long-acting contraceptives or implanted long-acting contraceptives within 28 days prior to screening;
- Participants who have used any known inducers or inhibitors of hepatic enzymes (e.g., grapefruit, orange juice, etc.) within 28 days prior to screening or during the trial period;
- Participants with any electrocardiogram (ECG) abnormality considered clinically significant by the investigator, including but not limited to: QTcF interval ≥450 ms, or a history of QTcF interval prolongation; PR interval ≥210 ms; QRS duration ≥120 ms; or a history of arrhythmia, syncope related to arrhythmia, use of a cardiac pacemaker, or other cardiac-related conditions. Note: Conditions include but are not limited to: heart failure; hypokalemia; atrial fibrillation, atrial flutter, premature atrial contractions, premature ventricular contractions, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; personal or family history of Long QT Syndrome (LQTS); or family history of sudden death;
- Participants with one or more abnormal vital signs at screening: aural temperature >37.5°C, pulse rate >100 beats per minute, systolic blood pressure ≥140 mmHg or <90 mmHg, diastolic blood pressure ≥90 mmHg or <50 mmHg;
- Participants who smoked an average of more than 5 cigarettes per day within 3 months prior to screening, or who are unable to discontinue the use of any tobacco products during the trial period；
- Participants who habitually consumed excessive amounts of xanthine- or caffeine-containing foods, beverages, or other items that may affect drug absorption, distribution, metabolism, or excretion within 1 month prior to screening and are unwilling to abstain during the trial. Examples include: coffee (>1100 mL daily), tea (>2200 mL daily), cola (>2200 mL daily), energy drinks (>1100 mL daily), chocolate (>510 g daily);
- Participants with alcohol abuse: alcohol consumption exceeding 14 units per week within 1 month prior to signing the informed consent form (1 unit = 285 mL of beer, 25 mL of spirits, or 150 mL of wine)；
- Participants with a positive alcohol breath test (>0 mg/100 mL) or those unable to abstain from alcohol during the trial period;
- Participants with a positive result for any of the following: Hepatitis B virus surface antigen (HBsAg), anti-Hepatitis C virus antibody (Anti-HCV), Treponema pallidum specific antibody, or anti-Human Immunodeficiency Virus antibody (Anti-HIV);
- Participants with a history of drug abuse and/or use of illicit drugs within 3 months prior to screening;
- Participants with a positive urine drug screen;
- Participants with a history of needle phobia, blood phobia, or intolerance to venipuncture for blood sampling;
- Participants who are pregnant, breastfeeding, or have a positive β-HCG pregnancy test;
- Participants with specific dietary requirements who cannot comply with the standardized diet and schedule;
- Participants deemed unsuitable for participation in this study by the investigator for any other reason.
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
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality
Xiaojie Wu, 86-13524686330, maomao_xj@163.com
About this study
Official title: A Phase І, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYH2085 in Chinese Healthy Participants
Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.
- Conditions
- Healthy Participants
- Being tested
- SYH2085, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2085Drug
oral administration
PlaceboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| SYH2085 SAD experimental group | Experimental | Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1. Receives: Drug: SYH2085 |
| Placebo SAD group | Placebo comparator | Participants in SAD experimental groups will receive a single oral administration of placebo on Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of adverse events (AEs)
Measured: Pre-dose and multiple timepoints no less than 22 days
Secondary outcomes (3)
Area under the concentration-time curve (AUC)
Measured: Pre-dose and multiple timepoints no less than 22 days
Plasma Maximum concentration (Cmax)
Measured: Pre-dose and multiple timepoints no less than 22 days
Half-Life (t1/2)
Measured: Pre-dose and multiple timepoints no less than 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start12 Jan 2026
- Primary completion12 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Model description
- Drug: SYH2085 Other: Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412353
- Sponsor's protocol ID
- SYH2085-001
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase І, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SYH2085 in Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT07412353
- Acronym / sponsor ID
- SYH2085-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
Randomized, double-blind and placebo-controlled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of SYH2085 and its food effect in China healthy adult participants. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending dose of SYH2085 tablet. Part 2 is to assess the food effect on SYH2085 at a selected dose in a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: SYH2085 Other: Placebo
| Arm | Type | Receives |
|---|---|---|
| SYH2085 SAD experimental group | Experimental | Drug: SYH2085Participants in SAD experimental groups will receive a single oral administration of SYH2085 tablet on Day 1. |
| Placebo SAD group | Placebo comparator | Drug: PlaceboParticipants in SAD experimental groups will receive a single oral administration of placebo on Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of 18 - 45 years (inclusive), male or female; BMI: 19.0-28.0 kg/m^2 (inclusive), with a minimum weight of 50.0 kg (inclusive) for male and 45.0 kg (inclusive) for female;
- Normal vital signs; Normal physical examination; Normal ECG findings; Normal laboratory examination; Normal imaging examination (X-ray);
- Participants and their partners agree to use effective and reliable contraceptive methods to avoid pregnancy, and male subjects had no plans to donate sperm, and female subjects had no plans to donate eggs, from the time they signed the informed consent to 3 months after the end of the study;
- Participants must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent.
Key exclusion criteria (24 listed)
- History of hypersensitivity or allergy to drug or food, or any component of the study drug；
- Participants with a history of serious diseases, including pancreas, cardiovascular, liver, kidney, blood and lymphatic, central nervous system, and gastrointestinal systems, or other important diseases that may affect the absorption, metabolism, or excretion of the study drug;
- History of gastrointestinal surgery or resection that may alter the absorption and/or elimination of orally administered drugs (except for appendectomy);
- Participants who have undergone any surgical procedure within 6 months prior to the trial;
- Participants with a history of respiratory or systemic acute infection within 2 weeks prior to screening;
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 |
|---|---|---|
| SYH2085oral administration | Drug | SYH2085 SAD experimental group |
| Placebooral administration | Drug | Placebo SAD group |
Primary outcome
The Number of adverse events (AEs)
Time frame: Pre-dose and multiple timepoints no less than 22 days
3 secondary outcomes
Area under the concentration-time curve (AUC)
Time frame: Pre-dose and multiple timepoints no less than 22 days
Plasma Maximum concentration (Cmax)
Time frame: Pre-dose and multiple timepoints no less than 22 days
Half-Life (t1/2)
Time frame: Pre-dose and multiple timepoints no less than 22 days
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 17 Feb 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 SYH2085 in people with Healthy Participants, 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 4 inclusion and 24 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 17 Feb 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 (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of adverse events (AEs) (time frame: Pre-dose and multiple timepoints no less than 22 days). 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 17 Feb 2026.