Actively Recruiting
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2026-03-02
26
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.
CONDITIONS
Official Title
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy subjects aged 18 to 45 years, any gender
- Voluntarily agree to participate and sign informed consent
- Men weighing at least 50 kg, women weighing at least 45 kg, BMI between 19 and 28 kg/m2
- Normal or clinically insignificant results from vital sign assessment, physical exam, blood and urine tests, blood biochemistry, coagulation, pregnancy test (if applicable), 12-lead ECG, chest X-ray or lung CT
- Willing to receive meningococcal and pneumococcal vaccines at least 14 days before randomization
You will not qualify if you...
- History of drug or food allergies or significant hypersensitivity to study drugs or related compounds
- History of serious diseases affecting major body systems unless approved by researcher
- First-degree relatives or personal history of meningococcal infection
- Contraindications to meningococcal vaccination such as epilepsy or brain diseases
- Active or suspected infections within 14 days prior to screening
- History of recurrent infections or use of systemic antibiotics within 90 days before administration
- History or diagnosis of Gilbert syndrome
- Treatment with blood products within 6 months prior to administration
- Major surgery within 4 weeks prior to administration or incomplete recovery from invasive procedures
- Positive for syphilis, AIDS, active hepatitis B or C
- History of malignant tumors
- Use of any drugs or health supplements within 2 weeks before administration unless approved by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Ding Chief Pharmacist, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
4
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