Respiratory Syncytial Virus (RSV)Early Phase 1NCT07106918
A Clinical Trial of SIBP-A16 Injection in Healthy Adults
A Early Phase 1 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 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy 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
- 140 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2025to 30 Apr 2027
- Phase
- Early Phase 1
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
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, 1 recruiting
- Recruiting
Wuhan Jinyintan Hospital
Wuhan
Chao Ling Huang, 027-85509839, 88071718@qq.com
About this study
Official title: 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 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
Read the detailed description
This study plans to set up 5 queues, with queues 1, 3, 4, and 5 each containing 20 participants in the experimental group and 4 participants in the placebo group. Queue 2 contains 20 participants in the experimental group, 20 participants in the positive control group, and 4 participants in the placebo group. The total number of participants included in the five queues is 140. SIBP-A16 injection and placebo will be administered in four different doses and two different ways of administration. The study adopted a sequential injection design. After completing a 14-day preliminary safety observation of drug administration in the previous group, the Safety Review Committee (SRC) will conduct a preliminary safety assessment. Once the SRC evaluation results are safe (not meeting the dose escalation termination criteria), the next group will be enrolled.
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- SIBP-A16 injection, Nirsevimab, SIBP-A16 buffer solution
- Keywords
- Respiratory syncytial virus, SIBP-A16, safety, tolerability, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-A16 injectionBiological
Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
NirsevimabBiological
Single administration via intramuscular.
SIBP-A16 buffer solutionOther
Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: SIBP-A16 injection |
| Nirsevimab | Active comparator | Participants injected Nirsevimab will compare with participants in dose 2 experimental group. Receives: 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 Receives: Other: 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 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.
Measured: 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.
Measured: From day 1 to day 361 after administration
Secondary outcomes (3)
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: Based on multiple pharmacokinetic blood collection points specified in the protocol
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: Based on multiple pharmacokinetic blood collection points specified in the protocol
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: Based on multiple pharmacokinetic blood collection points specified in the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start17 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chao lin Huang, Principal investigator, Wuhan Jinyintan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106918
- Sponsor's protocol ID
- SIBP-A16-I
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo/Positive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT07106918
- Acronym / sponsor ID
- SIBP-A16-I
- Conditions
- Respiratory Syncytial Virus (RSV)
- Keywords
- Respiratory syncytial virus, SIBP-A16, safety, tolerability, pharmacokinetics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Aug 2025 (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 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
Detailed description
This study plans to set up 5 queues, with queues 1, 3, 4, and 5 each containing 20 participants in the experimental group and 4 participants in the placebo group. Queue 2 contains 20 participants in the experimental group, 20 participants in the positive control group, and 4 participants in the placebo group. The total number of participants included in the five queues is 140. SIBP-A16 injection and placebo will be administered in four different doses and two different ways of administration. The study adopted a sequential injection design. After completing a 14-day preliminary safety observation of drug administration in the previous group, the Safety Review Committee (SRC) will conduct a preliminary safety assessment. Once the SRC evaluation results are safe (not meeting the dose escalation termination criteria), the next group will be enrolled.
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 |
|---|---|---|
| SIBP-A16 injection | Experimental | Biological: SIBP-A16 injectionStrength: 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. |
| Nirsevimab | Active comparator | Biological: NirsevimabParticipants injected Nirsevimab will compare with participants in dose 2 experimental group. |
| SIBP-A16 buffer solution | Placebo comparator | Other: SIBP-A16 buffer solutionParticipants in the placebo group from different queues will receive the same dose as the corresponding experimental group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
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 injectionSingle administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose. | Biological | SIBP-A16 injection |
| NirsevimabSingle administration via intramuscular. | Biological | Nirsevimab |
| SIBP-A16 buffer solutionSingle administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose. | Other | SIBP-A16 buffer solution |
Primary outcome
AE (Adverse Events)
Time frame: From day 1 to day 361 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 361 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 361 after administration
Adverse events defined in the protocol that require special attention, such as abnormal liver function, etc.
3 secondary outcomes
AUC (Area Under The Plasma Concentration Versus Time Curve)
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
Cmax (Peak Plasma Concentration)
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
Tmax (Peak Time)
Time frame: Based on multiple pharmacokinetic blood collection points specified in the protocol
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 25 Nov 2025.
- 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.
Chao lin Huang principal investigator
Wuhan Jinyintan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 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 5 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dan dan Chen, Master (+862162800991, 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 361 after administration). The study lists 3 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 25 Nov 2025.