SSS55 safety and how the body handles it in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-dose Phase 1 trial in healthy adults that examines safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy signals. Four dose groups were planned with sentinel dosing: the first two subjects in each group were randomized 1:1 to SSS55 or placebo and observed for 8 days before dosing the remainder of the group. Participants are adults aged 18–45 meeting weight and BMI criteria and must be willing to receive specified vaccines before randomization. The trial is sponsored by Shenyang Sunshine Pharmaceutical and conducted at Shanghai General Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy subjects aged 18 to 45 years old (including the boundary value), regardless of gender;
2. The subjects voluntarily participated in the clinical trial and signed the informed consent form;
3. Men with a weight of ≥50 kg, women with a weight of ≥45 kg, and those with a body mass index (BMI) ranging from 19 to 28 kg/m2 (including the critical value);
4. Those who underwent vital sign assessment, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, pregnancy examination (for women of childbearing age), 12-lead ECG, chest X-ray/lung CT during screening, and the results showed no abnormalities or the abnormalities had no clinical significance;
5. Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization.

Exclusion Criteria:

* 1\) Those with a clear history of drug or food allergies, or a known history of hypersensitivity reactions that are clinically significant to the research intervention measures or related compounds or commonly used antibacterial agents;

  2\) Those with a history of any serious clinical diseases in the past or present, including but not limited to those in the digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, immune system, neuropsychiatric system, hematological system, etc. (except those deemed eligible for enrollment by the researcher);

  3\) First-degree relatives with a known history of meningococcal infection or a history of meningococcal infection;

  4\) Those with contraindications to meningococcal vaccination (with a history of epilepsy or other brain diseases, etc.);

  5\) There was or suspected active viral, bacterial, fungal or parasitic infection within 14 days prior to screening, including herpes, shingles or cold sores;

  6\) A history of recurrent infections of unknown cause; Or systemic antibiotics (intravenous antibiotics, oral antibiotics, etc., excluding topical application antibiotics) have been used within 90 days before administration;

  7\) There is a history of Gilbert syndrome or the researcher assesses that it meets the diagnostic criteria for the disease;

  8\) Received treatment with blood products within 6 months prior to administration;

  9\) Those who have undergone major surgical operations within 4 weeks prior to administration or have not fully recovered from any previous invasive procedures;

  10\) Suffering from syphilis (Treponema pallidum antibody positive) or AIDS (HIV antibody positive), or active hepatitis C (hepatitis C virus antibody positive), or active hepatitis B (hepatitis B surface antigen positive);

  11\) A history of malignant tumors in the past or present;

  12\) Any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health supplements have been used within 2 weeks before administration (if determined by the investigator, the time interval from the start of administration of the drug in this trial \> Five half-lives, and the corresponding subjects can also be enrolled.

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Ding Chief Pharmacist, Doctor of Medicine
• Email: shiyiphase1@126.com
• Phone: 86-13761642319

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Be SMART secure firearm storage counseling for hospitalized caregivers

  This program will test whether a short Be SMART video and handout help caregivers of hospitalized children store firearms more safely at home.

  Recruiting at 2 sites Vanderbilt University Medical Center · Aurora, Colorado and 1 other locations · NCT06485141

• Registry for patients undergoing coronary intervention with orbital atherectomy

  This study is collecting information on patients with hard-to-treat heart blockages who are getting a specific procedure called orbital atherectomy to see how safe and effective it is.

  Recruiting at 2 sites Miedziowe Centrum Zdrowia SA · Legnica, Lower Silesian Voivodeship and 1 other locations · NCT06451146

• Evaluation of a new bone graft substitute for tooth extraction sites

  This study is testing a new bone graft substitute called Wishbone HA to see if it works as well as a standard option for helping people heal after tooth extractions.

  Recruiting at 5 sites Wishbone SA · Louvain-la-Neuve, Brabant Wallon and 4 other locations · NCT06383377

• Registry for patients with refractory angina undergoing Coronary Sinus Reducer implantation

  This study is testing if a new device called the Coronary Sinus Reducer can help people with severe chest pain who haven't found relief from other treatments.

  Recruiting at 2 sites Miedziowe Centrum Zdrowia SA · Lubin, Lower Silesian Voivodeship and 1 other locations · NCT06288165

• Evaluating bifurcation coronary interventions using two techniques

  This study looks at how well two different stenting techniques work for patients with heart artery blockages to see which one is safer and more effective.

  Recruiting at 2 sites Miedziowe Centrum Zdrowia SA · Legnica, Lower Silesian Voivodeship and 1 other locations · NCT06284057

• Evaluating the impact of pain management on patients' lives

  This study looks at how pain management services can improve the lives of adults with chronic pain by checking their health, social life, and job situation.

  Recruiting Salem Anaesthesia Pain Clinic · Surrey, British Columbia · NCT06076512

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.