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Tests treatment safety and results for Safety Issues
Official title Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
ClinicalTrials.gov ID: NCT07058779
What this study is testing
What is SSS55?
SSS55 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for safety issues.
Also referred to as SSS55 injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people aged 18 to 45 years old (including the boundary value), regardless of gender;
- The people voluntarily participated in the clinical trial and signed the informed consent form;
- 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...
- Those who underwent vital sign assessment, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, pregnancy...
- Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization.
You likely can't join if
- 1) Those with a clear history of drug or food allergies, or a known history of hypersensitivity reactions that are clinically significant to the...
- 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...
- 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...
- 6) A history of recurrent infections of unknown cause; Or systemic antibiotics (intravenous antibiotics, oral antibiotics, etc., excluding topical...
See the full eligibility criteria
- Healthy people aged 18 to 45 years old (including the boundary value), regardless of gender;
- The people voluntarily participated in the clinical trial and signed the informed consent form;
- 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);
- 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...
- Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.