BridgeMD
New treatment option for Respiratory Syncytial Virus (RSV)
Official title A Clinical Trial of SIBP-A16 Injection in Healthy Adults
ClinicalTrials.gov ID: NCT07106918
What this study is testing
What is SIBP-A16 injection?
SIBP-A16 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for respiratory syncytial virus (rsv).
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 is a randomized, double-blind, placebo/positive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults
- 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 individuals aged 18 to 45 on the day of enrollment, regardless of gender.
- Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, BMI between 19.0 and 27.0 kg/m2 (including critical values).
- Screening period physical examination, vital sign examination, 12 lead electrocardiogram, chest X-ray or clinical laboratory examination, and other...
- Individuals who voluntarily participate in clinical trials and sign informed consent forms.
- Individuals are able to communicate well with the researchers and understand and comply with the requirements of this study.
You likely can't join if
- Known to have a history of serious clinical diseases such as mental system, circulatory system, endocrine system, digestive system, respiratory...
- Individuals with a history of drug allergies or specific allergies, or individuals with allergies, or those known to be allergic to the components or...
- During the screening period, individuals with abnormal results from physical examination, laboratory tests and clinical significance were identified...
- During the screening period, male individuals with QTcF ≥ 450 milliseconds and female individuals with QTcF ≥ 470 milliseconds on electrocardiogram.
- Individuals who have received monoclonal/polyclonal antibody drugs within 6 months prior to screening.
- Individuals have received immunoglobulin or blood product treatment within 6 months prior to screening.
See the full eligibility criteria
- Healthy individuals aged 18 to 45 on the day of enrollment, regardless of gender.
- Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, BMI between 19.0 and 27.0 kg/m2 (including critical values).
- Screening period physical examination, vital sign examination, 12 lead electrocardiogram, chest X-ray or clinical laboratory examination, and other auxiliary examination results show normal or abnormal without clinical...
- Individuals who voluntarily participate in clinical trials and sign informed consent forms.
- Individuals are able to communicate well with the researchers and understand and comply with the requirements of this study.
- Known to have a history of serious clinical diseases such as mental system, circulatory system, endocrine system, digestive system, respiratory system, hematological and metabolic abnormalities, or any other diseases...
- Individuals with a history of drug allergies or specific allergies, or individuals with allergies, or those known to be allergic to the components or analogues of this drug.
- During the screening period, individuals with abnormal results from physical examination, laboratory tests and clinical significance were identified by the researchers as having an impact on the evaluation of this trial.
- During the screening period, male individuals with QTcF ≥ 450 milliseconds and female individuals with QTcF ≥ 470 milliseconds on electrocardiogram.
- Individuals who have received monoclonal/polyclonal antibody drugs within 6 months prior to screening.
- Individuals have received immunoglobulin or blood product treatment within 6 months prior to screening.
- Individuals who have received passive immune agents, immunosuppressants, or corticosteroids within the 6 months prior to screening.
- Individuals who experience acute illnesses such as fever ≥ 37.3 ℃ (armpit temperature) and diarrhea within one week before their first medication.
- Individuals experienced symptoms and signs of acute upper respiratory tract infection within 2 weeks prior to the first use of medication.
- Individuals who have received the respiratory syncytial virus (RSV) vaccine in the past.
- Individuals have received any vaccine within 30 days prior to screening.
- Select individuals who have smoked at least 5 cigarettes per day within the first 3 months and those who cannot quit smoking throughout the entire trial period.
- Individuals with an average weekly alcohol consumption of ≥ 14 units within the first 3 months of screening, or those who cannot abstain from alcohol during the trial period.
- Individuals have a history of long-term excessive consumption of tea, coffee, or caffeinated beverages.
- Individuals have used any medication or health supplement within the 14 days prior to screening.
- Individuals with a history of drug abuse/dependence or drug use within the past year prior to screening.
- Screening individuals who have participated in any drug clinical trials and have used the investigational drug within the previous 3 months.
- Individuals with a history of blood donation or significant bleeding within the previous 4 weeks prior to screening, or those planning to donate blood or blood components during the study period.
- Pregnant or lactating women.
- Those who have plans to conceive, donate sperm or eggs, or are unable to voluntarily take effective contraceptive measures during the trial period (including partners).
- Those who have special dietary requirements and cannot follow a reasonable and normal diet.
- The researchers believe that the individuals may have other situations that may affect compliance or be unsuitable to participate in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, 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 Wuhan, 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.