Actively Recruiting
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
Led by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Updated on 2026-06-08
40
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SYH2061 in healthy adult volunteers. This study is a randomized, double-blind, placebo-controlled, single-ascending dose trial designed to gather important early information about SYH2061. The trial is sponsored by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. and focuses on healthy subjects aged 18 to 55 years. Participants are randomly assigned to receive a single subcutaneous injection of either SYH2061 or a placebo on Day 1. The study follows a single-dose design, assessing the effects of the drug compared to placebo. The double-blind setup means neither participants nor researchers know who receives the drug or placebo during the trial. Throughout the study, participants will undergo physical exams, vital signs monitoring, ECGs, chest X-rays, abdominal ultrasounds, and laboratory tests. Researchers will track adverse events up to Day 337 and measure SYH2061 levels in the blood for up to 72 hours after dosing. They will also monitor changes in complement system components and immune responses over time. The study lasts several months to ensure safety and gather detailed pharmacological data.
CONDITIONS
Brief Title
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be informed about the study, understand the procedures and risks, and voluntarily sign the consent form
- Healthy males or females aged 18 to 55 years inclusive
- Body mass index between 19.0 and 28.0 kg/m2 inclusive, with weight of at least 50 kg for males and 45 kg for females
- Normal or clinically insignificant abnormalities in physical exam, vital signs, ECG, chest X-ray, abdominal ultrasound, and lab tests at screening
- Vaccinated against meningococcal ACYW135 and pneumococcal vaccines at least 14 days prior or within past 3 years with valid documentation
- Agreement to use effective contraception from 14 days before consent until 6 months after drug administration
- Ability to communicate well and complete the study as per protocol
You will not qualify if you...
- History or current significant medical conditions including circulatory, hematological, respiratory, endocrine, urinary, digestive, neurological, psychiatric, autoimmune diseases, malignancies, severe trauma, or others affecting study results
- History of splenectomy or absence of spleen function
- Known or suspected complement deficiency or impaired activity
- History of meningococcal infection or positive test for Neisseria meningitides
- Frequent exposure to Neisseria meningitides or recent/planned travel to endemic regions
- Recent recurrent or chronic infections or infections needing antibiotics within 3 months
- Active infections including herpes or cold sores within 14 days before dosing
- History or presence of tuberculosis or positive T-SPOT test
- Major surgery within 6 months before screening or planned surgery during study
- Severe allergies or allergy to study drug components or vaccines
- Allergy to beta-lactam antibiotics or ciprofloxacin or unwillingness to use antibiotic prophylaxis
- Intolerance to subcutaneous injections or skin conditions affecting injection site
- Abnormal liver function tests above normal limits
- Reduced kidney function with eGFR below 90 mL/min/1.73 m2
- Prolonged QT/QTc interval on ECG
- Positive for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Use of drugs or supplements within 14 days or 5 half-lives before dosing
- Prior complement inhibitor treatment within 6 months or 5 half-lives
- Recent live or live-attenuated vaccines within 28 days or planned during study
- Recent blood or platelet donation above specified limits
- History of drug abuse or positive drug screen
- Excessive alcohol use or inability to stop alcohol during study
- Smoking more than 5 cigarettes daily or unwillingness to avoid tobacco
- Participation in other clinical trials within relevant timeframes
- Pregnancy, lactation, recent contraceptive use, or unprotected sex in females of childbearing potential
- Any other condition that could interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours post-dose
Participants receive a single subcutaneous injection of SYH2061 or placebo and are monitored closely for safety, tolerability, and drug effects.
Multiple visits within 72 hours post-dose
Duration - Up to Day 337
Participants are observed for safety and pharmacodynamic outcomes, including complement levels and antibody incidence, up to approximately 11 months after dosing.
Periodic visits over 11 months
Trial Site Locations
Total: 1 location
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
W
Wei Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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