SIBP-A16 injections in healthy adults to find safe doses and routes

A Randomized, Double-blind, Placebo/Positive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Healthy Adults

This trial will test different doses and ways of giving SIBP-A16 to see if they are safe and how the body handles the drug in healthy adults.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Institute Of Biological Products (Industry-sponsored)
• Locations: 1 site (Wuhan)
• Trial ID: NCT07106918 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo- and positive-control Phase Ia trial will enroll 140 healthy adults to study the safety, tolerability, and pharmacokinetics of SIBP-A16. Participants are assigned across five sequential cohorts with four dose levels and two administration routes, and each cohort proceeds after a 14-day safety observation and Safety Review Committee clearance. One cohort includes a positive control arm using nirsevimab while placebo is used for blinding in all cohorts. The study collects adverse event data, vital signs, ECGs, laboratory tests, and blood drug levels to characterize safety and pharmacokinetics.

Who should consider this trial

Good fit: Healthy men and women aged 18–45 with body weight and BMI within the study limits who pass screening tests and can give informed consent are the intended participants.

Not a fit: People outside the 18–45 age range or with significant medical conditions, immunosuppression, pregnancy, or other exclusionary factors are unlikely to receive benefit from this early healthy-volunteer trial.

Why it matters

Potential benefit: If successful, the trial could identify safe doses and delivery methods to advance SIBP-A16 as a preventive option against RSV.

How similar studies have performed: Related monoclonal antibodies such as nirsevimab have shown protective effects against RSV in infants, but SIBP-A16 is novel and its safety and dosing in adults are untested.

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

Where this trial is running

Wuhan

• Wuhan Jinyintan Hospital — Wuhan, China (Recruiting)

Study contacts

• Principal investigator: Chao lin Huang — Wuhan Jinyintan Hospital
• Study coordinator: Dan dan Chen, Master

Conditions Respiratory Syncytial Virus; Respiratory syncytial virus; SIBP-A16; safety; tolerability; pharmacokinetics