NCT07106918 A Clinical Trial of SIBP-A16 Injection in Healthy Adults
| NCT ID | NCT07106918 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Institute Of Biological Products |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-08-17 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2025-08-17 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion 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 significance as judged by the researcher. * 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. Exclusion Criteria: * 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 that can interfere with the test results. * 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
Contact & Investigator
Chao lin Huang
PRINCIPAL INVESTIGATOR
Wuhan Jinyintan Hospital
Frequently Asked Questions
Who can join the NCT07106918 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106918 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07106918 currently recruiting?
Yes, NCT07106918 is actively recruiting participants. Contact the research team at ddchen.sh@sinopharm.com for enrollment information.
Where is the NCT07106918 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07106918 clinical trial?
NCT07106918 is sponsored by Shanghai Institute Of Biological Products. The principal investigator is Chao lin Huang at Wuhan Jinyintan Hospital. The trial plans to enroll 140 participants.