Healthy SubjectsPhase 1NCT07241910
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061
A Phase 1 study testing SYH2061 in people with Healthy Subjects, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SYH2061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2025to 1 Apr 2027
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
- Healthy male or female subjects, aged 18 to 55 years (inclusive);
- Body mass index ranging from 19.0 to 28.0 kg/m2 (inclusive), with a body weight of ≥ 50 kg for males and ≥ 45 kg for females;
- The results of various examinations, such as physical examination, vital signs, ECG, chest X-ray, abdominal B-scan ultrasound, and laboratory tests at screening are normal or abnormal without clinical significance;
- Vaccinated against meningococcal ACYW135 vaccine and pneumococcal vaccine at least 14 days prior to the first dose, or have valid documentation of receiving the respective vaccinations within the past 3 years prior to dosing as evaluated by the investigator.;
- Subjects and their partners agree to use effective and reliable contraceptive methods from 14 days before signing the ICF until 6 months after drug administration; male subjects agree not to donate sperm and female subjects agree not to donate ova from signing the ICF until 6 months after study drug administration;
- Subjects are able to communicate well with the investigator and can complete the study in accordance with the protocol.
Who cannot join
- History and/or current presence of clinically significant medical conditions, including but not limited to circulatory system disorders, hematological or hematopoietic system disorders, respiratory disorders, endocrine disorders, urinary system disorders, digestive system disorders, neurological or psychiatric disorders, autoimmune diseases, malignant tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results in the opinion of the investigator;
- History of splenectomy, or functional or anatomical asplenia;
- Known or suspected hereditary or acquired complement deficiency or impaired complement activity, or complement activity below the normal range at screening;
- History of meningococcal infection, or positive Neisseria meningitides test at screening;
- Subjects who are frequently exposed to Neisseria meningitides (e.g., research, industrial, or clinical laboratory personnel, military personnel during recruit training, daycare center staff, etc.), and those who have traveled to or plan to travel to endemic areas for meningococcal meningitis (e.g., India, sub-Saharan Africa, Saudi Arabia) within 6 months before dosing or during the course of the study;
- History of recurrent or chronic infections (e.g., recurrent upper respiratory tract infection, diarrhoea, etc.) or infections requiring systemic antibiotic therapy within 3 months before dosing;
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- Presence or suspicion of active viral, bacterial, fungal, or parasitic infection including herpes, herpes zoster, or cold sores within 14 days before dosing;
- History or current presence of latent or active pulmonary tuberculosis, or positive T-SPOT test at screening;
- History of major surgery within 6 months prior to screening, or plan to undergo major surgery during the course of the study;
- Subjects with severe allergic diseases or allergic constitution (≥ 3 drug or food allergies), or a known history of allergy to the investigational drug components, oligonucleotide drugs, or vaccinations;
- Subjects who are allergic to β-lactam antibiotics (e.g., penicillin, cephalosporins) or ciprofloxacin, or have any contraindications, or unwilling to use antibiotic prophylaxis as specified in the protocol;
- Intolerance to subcutaneous injection, or presence of abdominal scars (from surgery, burns, etc.) that affect subcutaneous administration, and any skin abnormalities and/or tattoos that may affect the safety assessment of the injection site;
- Any of the following liver function test results: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), γ-glutamyl transferase (GGT), or alkaline phosphatase (ALP) above the upper limit of normal at screening;
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 (calculated by the simplified MDRD formula) at screening;
- Prolonged QT/QTc interval at screening or baseline (QTcF > 450 ms for males, > 470 ms for females);
- Positive result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus (HIV) antigen/antibody, or Treponema pallidum antibody;
- Use of any prescription drugs, over-the-counter drugs, herbal medicines or vitamin and dietary supplements within 14 days or 5 half-lives (whichever is longer) before dosing;
- Received complement inhibitor treatment (e.g., Eculizumab, Crovalimab, etc.) within 6 months or 5 half-lives (whichever is longer) before dosing;
- Received live or live-attenuated vaccines within 28 days before dosing, or plan to receive such vaccines during the course of the study (except for vaccinations planned by the study protocol);
- Blood loss or blood donation of more than 200 mL within 3 months before screening (except for menstruation in females), or platelet donation within 2 weeks before screening;
- History of drug abuse, or use of illicit drugs within 3 months before screening, or habitual use of any psychotropic drugs (including herbal medicines), or a positive urine drug screen;
- Regular alcohol consumption within 6 months before screening, defined as weekly alcohol consumption exceeding 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine), or inability to stop alcohol intake as required by the protocol during the study, or a positive blood alcohol test;
- Average daily smoking of more than 5 cigarettes (or an equivalent amount of tobacco in e-cigarettes) within 3 months before screening, or unwilling to avoid using any tobacco products as required by the protocol during the study;
- Participation in any clinical trial within 3 months before screening (or within 12 months before screening for oligonucleotide drugs)
- In addition to the above requirements, female subjects who meet the following criteria should also be excluded: a. Pregnant or lactating women; b. Use of oral contraception within 28 days prior to screening; c. Use of long-acting estrogen and/or progesterone injections and/or implants within 6 months prior to screening; d. females of childbearing potential who had unprotected sexual intercourse with their partner within 28 days prior to dosing.
- Any other conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
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
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Wei Hu, Ph.D, 13856086475, huwei@ahmu.edu.com
About this study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2061 in Healthy Subjects
This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.
- Conditions
- Healthy Subjects
- Being tested
- SYH2061, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2061Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SYH2061 group | Experimental | Subjects in experimental group will receive a single subcutaneous injection of SYH2061 on Day 1. Receives: Drug: SYH2061 |
| Placebo group | Placebo comparator | Subjects in placebo group will receive a single subcutaneous injection 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.
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
To assess the safety and tolerability of SYH2061 in healthy subjects
Measured: Up to Day 337
Secondary outcomes (11)
Maximum observed plasma concentration (Cmax) of SYH2061
To characterize the Cmax of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Time to maximum observed plasma concentration (Tmax) of SYH2061
To characterize the Tmax of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) of SYH2061
To characterize the AUClast of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Area under the concentration-time curve from zero to infinity (AUCinf) of SYH2061
To characterize the AUCinf of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Terminal elimination half-life (t1/2) of SYH2061
To characterize the t1/2 of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Apparent clearance (CL/F) of SYH2061
To characterize the CL/F of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Apparent volume of distribution (Vz/F) of SYH2061
To characterize the Vz/F of SYH2061 in healthy subjects
Measured: Up to 72 hours post-dose
Percent change from baseline in complement C5 and its fragments C5a and C5b-9
To assess the PD effects of SYH2061 in healthy subjects
Measured: Up to Day 337
Percent change from baseline in complement alternative pathway (CAP)
To assess the PD effects of SYH2061 in healthy subjects
Measured: Up to Day 337
Percent change from baseline in complement classical pathway (CCP)
To assess the PD effects of SYH2061 in healthy subjects
Measured: Up to Day 337
Incidence of ADA
To assess the immunogenicity of SYH2061 in healthy subjects
Measured: Day85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start23 Dec 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241910
- Sponsor's protocol ID
- SYH2061-001
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SYH2061 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07241910
- Acronym / sponsor ID
- SYH2061-001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 21 Nov 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, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYH2061 group | Experimental | Drug: SYH2061Subjects in experimental group will receive a single subcutaneous injection of SYH2061 on Day 1. |
| Placebo group | Placebo comparator | Drug: PlaceboSubjects in placebo group will receive a single subcutaneous injection of placebo on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF;
- Healthy male or female subjects, aged 18 to 55 years (inclusive);
- Body mass index ranging from 19.0 to 28.0 kg/m2 (inclusive), with a body weight of ≥ 50 kg for males and ≥ 45 kg for females;
- The results of various examinations, such as physical examination, vital signs, ECG, chest X-ray, abdominal B-scan ultrasound, and laboratory tests at screening are normal or abnormal without clinical significance;
- Vaccinated against meningococcal ACYW135 vaccine and pneumococcal vaccine at least 14 days prior to the first dose, or have valid documentation of receiving the respective vaccinations within the past 3 years prior to dosing as evaluated by the investigator.;
Key exclusion criteria (26 listed)
- History and/or current presence of clinically significant medical conditions, including but not limited to circulatory system disorders, hematological or hematopoietic system disorders, respiratory disorders, endocrine disorders, urinary system disorders, digestive system disorders, neurological or psychiatric disorders, autoimmune diseases, malignant tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results in the opinion of the investigator;
- History of splenectomy, or functional or anatomical asplenia;
- Known or suspected hereditary or acquired complement deficiency or impaired complement activity, or complement activity below the normal range at screening;
- History of meningococcal infection, or positive Neisseria meningitides test at screening;
- Subjects who are frequently exposed to Neisseria meningitides (e.g., research, industrial, or clinical laboratory personnel, military personnel during recruit training, daycare center staff, etc.), and those who have traveled to or plan to travel to endemic areas for meningococcal meningitis (e.g., India, sub-Saharan Africa, Saudi Arabia) within 6 months before dosing or during the course of 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 |
|---|---|---|
| SYH2061subcutaneous injection | Drug | SYH2061 group |
| Placebosubcutaneous injection | Drug | Placebo group |
Primary outcome
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
Time frame: Up to Day 337
To assess the safety and tolerability of SYH2061 in healthy subjects
11 secondary outcomes
Maximum observed plasma concentration (Cmax) of SYH2061
Time frame: Up to 72 hours post-dose
Time to maximum observed plasma concentration (Tmax) of SYH2061
Time frame: Up to 72 hours post-dose
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) of SYH2061
Time frame: Up to 72 hours post-dose
Area under the concentration-time curve from zero to infinity (AUCinf) of SYH2061
Time frame: Up to 72 hours post-dose
Terminal elimination half-life (t1/2) of SYH2061
Time frame: Up to 72 hours post-dose
Apparent clearance (CL/F) of SYH2061
Time frame: Up to 72 hours post-dose
Apparent volume of distribution (Vz/F) of SYH2061
Time frame: Up to 72 hours post-dose
Percent change from baseline in complement C5 and its fragments C5a and C5b-9
Time frame: Up to Day 337
Percent change from baseline in complement alternative pathway (CAP)
Time frame: Up to Day 337
Percent change from baseline in complement classical pathway (CCP)
Time frame: Up to Day 337
Incidence of ADA
Time frame: Day85
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 8 Jun 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 SYH2061 in people with Healthy Subjects, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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 7 inclusion and 26 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 8 Jun 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?
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0 (time frame: Up to Day 337). 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 8 Jun 2026.