A Clinical Trial of SIBP-A16 Injection in Healthy Adults

NCT07106918 | Recruiting Early Phase 1 DMC

• 1 other identifier: SIBP-A16-I
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

Respiratory syncytial virus; SIBP-A16; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• AE (Adverse Events)

  That is adverse events, any adverse events that occurred to the participant during the study period.

  From day 1 to day 361 after administration

• SAE (Serious Adverse Events)

  That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

  From day 1 to day 361 after administration

• Adverse Event of Special Interest (AESI)

  Adverse events defined in the protocol that require special attention, such as abnormal liver function, etc.

  From day 1 to day 361 after administration

Secondary Outcomes (3)

• AUC (Area Under The Plasma Concentration Versus Time Curve)

  Based on multiple pharmacokinetic blood collection points specified in the protocol

• Cmax (Peak Plasma Concentration)

  Based on multiple pharmacokinetic blood collection points specified in the protocol

• Tmax (Peak Time)

  Based on multiple pharmacokinetic blood collection points specified in the protocol

Other Outcomes (1)

• Level of Anti-drug antibody (ADA)

  Before injection, on the 15th, 31st, 91st, 151st, 271st, and 361st days after administration

Study Arms (3)

SIBP-A16 injection

EXPERIMENTAL

Strength: dose 1, dose 2 dose 3 and dose 4. The participants enrolled will be randomly assigned to different dose groups, and they will be enrolled in groups according to the dose from low to high.

Biological: SIBP-A16 injection

Nirsevimab

ACTIVE COMPARATOR

Participants injected Nirsevimab will compare with participants in dose 2 experimental group.

Biological: Nirsevimab

SIBP-A16 buffer solution

PLACEBO COMPARATOR

Participants in the placebo group from different queues will receive the same dose as the corresponding experimental group

Other: SIBP-A16 buffer solution

Interventions

SIBP-A16 injection BIOLOGICAL

Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.

SIBP-A16 injection

Nirsevimab BIOLOGICAL

Single administration via intramuscular.

Nirsevimab

SIBP-A16 buffer solution OTHER

Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.

SIBP-A16 buffer solution

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Wuhan Jinyintan Hospital

Wuhan, China

RECRUITING

MeSH Terms

Interventions

nirsevimab

Study Officials

• Chao lin Huang

  Wuhan Jinyintan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan dan Chen, Master

CONTACT

+862162800991; ddchen.sh@sinopharm.com

Bin Wu, Bachelor

CONTACT

+862162800991; wubin50@sinopharm.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 17, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)