Respiratory Syncytial Virus (RSV)Phase 1/2NCT07363837
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
A Phase 1/2 study testing SIBP-A16 injection, Nirsevimab and SIBP-A16 buffer solution in people with Respiratory Syncytial Virus (RSV), run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants. Read more about this study
- Who is it for?
- Ages 0 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- SIBP-A16 injection, Nirsevimab and SIBP-A16 buffer solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 31 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to <35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;
- Infants with a body weight ≥3 kg at screening;
- Infants who are entering their first RSV infection season at screening;
- Parents/legal guardians of trial participants have signed the informed consent form;
- Parents/legal guardians of trial participants are able to understand and comply with the requirements and procedures of the protocol, including scheduled center visits, telephone interviews, and blood sample collection;
- Participants can complete the follow-up period, which is approximately 1 year after the administration of the study drug.
Who cannot join
- Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;
- Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;
- Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;
- Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;
- Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;
- Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;
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- Participants who have received any medication within 7 days prior to drug administration, except for: a) various vitamins and iron supplements; b) systemic over-the-counter medications (such as analgesics) for common pediatric symptoms, which may be used occasionally, as determined by the investigator;
- Participants with autoimmune diseases who are currently receiving, or are expected to receive according to the investigator's judgment, immunosuppressive therapy (including steroids, excluding topical steroids) during the trial period;
- Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;
- Known renal dysfunction or liver dysfunction;
- Known to have chronic lung disease (CLD)/bronchopulmonary dysplasia;
- Congenital respiratory abnormalities with clinical significance;
- Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;
- Suffering from chronic epilepsy or progressive or unstable neurological disorders;
- Those who have previously experienced or are suspected to have experienced life-threatening acute events, and are still deemed unsuitable for participating in clinical trials by the researchers;
- Known immune deficiency, including infection with human immunodeficiency virus (HIV);
- The mother is infected with HIV (unless it has been proven that the trial participant is not infected);
- The mother received the RSV vaccine during pregnancy;
- Have received any investigational drugs or participated in any intervention studies;
- Any other circumstances that the researcher believes may interfere with the evaluation of the study drug or the interpretation of the study results;
- The participants are the children of the researchers, their subordinate researchers, relatives, or staff members of the sponsor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Second Hospital, Sichuan University
Chengdu, Sichuan
Hanwen Liu, 86-18980602109, hanmin@vip.163.com
About this study
Official title: A Randomized, Double-blind, Placebo/Positive Control, Dose-finding Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.
Read the detailed description
This study established three study groups: the test drug group, the placebo group, and the positive control group. Four dose cohorts were set up: Cohort 1 (Dose 1), Cohort 2 (Dose 2), Cohort 3 (Dose 3), and Cohort 4 (Dose 2). A total of 36 participants were enrolled. The drug will be administered via intramuscular injection as a single dose. Initially, Cohort 1 enrolled 7 participants, who were randomly assigned to receive either one dose of the test drug or placebo. After completing the initial 14-day safety observation, if the dose escalation termination criteria were not triggered, participants were enrolled into Cohort 2 (11 participants, randomly assigned to receive either one dose of the test drug or placebo). Once Cohort 2 was fully enrolled, participants could be enrolled into Cohort 4 (7 participants, randomly assigned to receive either one dose of the positive control drug or placebo). After Cohort 2 completed the 14-day safety observation, participants were enrolled into Cohort 3 (11 participants, randomly assigned to receive either one dose of the test drug or placebo) following the same procedure. If the dose escalation termination criteria were triggered, the Data Monitoring Committee (DMC) would conduct a safety assessment and discuss with the research team and sponsor whether to terminate the dose escalation.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Keywords
- RSV, Preliminary efficacy, Premature and term infants, Pharmacokinetics, Safety, Tolerability
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A16 injectionDrug
Strength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection.
NirsevimabDrug
Participants will receive one dose of Nisibimab via intramuscular injection.
SIBP-A16 buffer solutionDrug
Participants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SIBP-A16 injection Receives: Drug: SIBP-A16 injection |
| Positive Comparator | Active comparator | Nirsevimab Receives: Drug: Nirsevimab |
| Placebo | Placebo comparator | SIBP-A16 buffer solution Receives: Drug: SIBP-A16 buffer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE (Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
Measured: From day 1 to day 360 after administration
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Measured: From day 1 to day 360 after administration
Adverse Event of Special Interest (AESI)
Adverse events defined in the protocol that require special attention, such as abnormal liver function, anaphylactic reaction, hypersensitivity reaction, etc.
Measured: From day 1 to day 360 after administration
New-onset chronic diseases (NOCD)
NOCD refer to chronic non-communicable diseases that emerge during clinical trials.
Measured: From day 1 to day 360 after administration
Secondary outcomes (5)
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Measured: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Tmax (Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
Measured: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Detecting RSV neutralizing antibody activity at various time points
The RSV neutralizing assay was used to analyze the neutralizing activity of participants against RSV at various time points (before administration, and on days 7, 30, 90, 150, and 360 after administration).
Measured: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Level of Anti-drug antibody (ADA)
If ADA is positive, further use validated analytical methods to detect the anti-SIBP-A16 neutralizing antibody (Nab).
Measured: Before injection, on the 30th, 150th and 360th days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanwen Liu, Principal investigator, West China Second Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363837
- Sponsor's protocol ID
- SIBP-A16-002
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo/Positive Control, Dose-finding Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants
- ClinicalTrials.gov ID
- NCT07363837
- Acronym / sponsor ID
- SIBP-A16-002
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- RSV, Preliminary efficacy, Premature and term infants, Pharmacokinetics, Safety, Tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.
Detailed description
This study established three study groups: the test drug group, the placebo group, and the positive control group. Four dose cohorts were set up: Cohort 1 (Dose 1), Cohort 2 (Dose 2), Cohort 3 (Dose 3), and Cohort 4 (Dose 2). A total of 36 participants were enrolled. The drug will be administered via intramuscular injection as a single dose. Initially, Cohort 1 enrolled 7 participants, who were randomly assigned to receive either one dose of the test drug or placebo. After completing the initial 14-day safety observation, if the dose escalation termination criteria were not triggered, participants were enrolled into Cohort 2 (11 participants, randomly assigned to receive either one dose of the test drug or placebo). Once Cohort 2 was fully enrolled, participants could be enrolled into Cohort 4 (7 participants, randomly assigned to receive either one dose of the positive control drug or placebo). After Cohort 2 completed the 14-day safety observation, participants were enrolled into Cohort 3 (11 participants, randomly assigned to receive either one dose of the test drug or placebo) following the same procedure. If the dose escalation termination criteria were triggered, the Data Monitoring Committee (DMC) would conduct a safety assessment and discuss with the research team and sponsor whether to terminate the dose escalation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SIBP-A16 injectionSIBP-A16 injection |
| Positive Comparator | Active comparator | Drug: NirsevimabNirsevimab |
| Placebo | Placebo comparator | Drug: SIBP-A16 buffer solutionSIBP-A16 buffer solution |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to <35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;
- Infants with a body weight ≥3 kg at screening;
- Infants who are entering their first RSV infection season at screening;
- Parents/legal guardians of trial participants have signed the informed consent form;
- Parents/legal guardians of trial participants are able to understand and comply with the requirements and procedures of the protocol, including scheduled center visits, telephone interviews, and blood sample collection;
Key exclusion criteria (21 listed)
- Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;
- Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;
- Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;
- Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;
- Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIBP-A16 injectionStrength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection. | Drug | Experimental group |
| NirsevimabParticipants will receive one dose of Nisibimab via intramuscular injection. | Drug | Positive Comparator |
| SIBP-A16 buffer solutionParticipants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection. | Drug | Placebo |
Primary outcome
AE (Adverse Events)
Time frame: From day 1 to day 360 after administration
That is adverse events, any adverse events that occurred to the participant during the study period.
SAE (Serious Adverse Events)
Time frame: From day 1 to day 360 after administration
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Adverse Event of Special Interest (AESI)
Time frame: From day 1 to day 360 after administration
Adverse events defined in the protocol that require special attention, such as abnormal liver function, anaphylactic reaction, hypersensitivity reaction, etc.
New-onset chronic diseases (NOCD)
Time frame: From day 1 to day 360 after administration
NOCD refer to chronic non-communicable diseases that emerge during clinical trials.
5 secondary outcomes
AUC (Area Under The Plasma Concentration Versus Time Curve)
Time frame: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Cmax (Peak Plasma Concentration)
Time frame: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Tmax (Peak Time)
Time frame: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Detecting RSV neutralizing antibody activity at various time points
Time frame: Before injection, on the 7th, 30th, 90th, 150th and 360th days after administration
Level of Anti-drug antibody (ADA)
Time frame: Before injection, on the 30th, 150th and 360th days after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanwen Liu principal investigator
West China Second Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SIBP-A16 injection, Nirsevimab and SIBP-A16 buffer solution in people with Respiratory Syncytial Virus (RSV), run by Shanghai Institute Of Biological Products at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dandan Chen, Master (86-021-62800991, ddchen.sh@sinopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE (Adverse Events) (time frame: From day 1 to day 360 after administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.