Safety IssuesPhase 1NCT07058779
Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects
A Phase 1 study testing SSS55 in people with Safety Issues, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues
- What is being tested?
- SSS55
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2025to Dec 2027
- Phase
- 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 subjects aged 18 to 45 years old (including the boundary value), regardless of gender;
- The subjects voluntarily participated in the clinical trial and signed the informed consent form;
- Men with a weight of ≥50 kg, women with a weight of ≥45 kg, and those with a body mass index (BMI) ranging from 19 to 28 kg/m2 (including the critical value);
- Those who underwent vital sign assessment, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, pregnancy examination (for women of childbearing age), 12-lead ECG, chest X-ray/lung CT during screening, and the results showed no abnormalities or the abnormalities had no clinical significance;
- Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization.
Who cannot join
- 1) Those with a clear history of drug or food allergies, or a known history of hypersensitivity reactions that are clinically significant to the research intervention measures or related compounds or commonly used antibacterial agents;
- 2) Those with a history of any serious clinical diseases in the past or present, including but not limited to those in the digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, immune system, neuropsychiatric system, hematological system, etc. (except those deemed eligible for enrollment by the researcher);
- 3) First-degree relatives with a known history of meningococcal infection or a history of meningococcal infection;
- 4) Those with contraindications to meningococcal vaccination (with a history of epilepsy or other brain diseases, etc.);
- 5) There was or suspected active viral, bacterial, fungal or parasitic infection within 14 days prior to screening, including herpes, shingles or cold sores;
- 6) A history of recurrent infections of unknown cause; Or systemic antibiotics (intravenous antibiotics, oral antibiotics, etc., excluding topical application antibiotics) have been used within 90 days before administration;
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- 7) There is a history of Gilbert syndrome or the researcher assesses that it meets the diagnostic criteria for the disease;
- 8) Received treatment with blood products within 6 months prior to administration;
- 9) Those who have undergone major surgical operations within 4 weeks prior to administration or have not fully recovered from any previous invasive procedures;
- 10) Suffering from syphilis (Treponema pallidum antibody positive) or AIDS (HIV antibody positive), or active hepatitis C (hepatitis C virus antibody positive), or active hepatitis B (hepatitis B surface antigen positive);
- 11) A history of malignant tumors in the past or present;
- 12) Any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health supplements have been used within 2 weeks before administration (if determined by the investigator, the time interval from the start of administration of the drug in this trial \> Five half-lives, and the corresponding subjects can also be enrolled.
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
Shanghai General Hospital
Shanghai, Shanghai Municipality
Chief Pharmacist, 86-13761642319, shiyiphase1@126.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SSS55 Injection in Healthy Subjects in China
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.
Read the detailed description
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.In this trial, four dose groups were preset. The initial dose and dose level were relatively low. Two subjects were planned to be enrolled and only received SSS55 administration. In the subsequent dose group, sentries were set up in each group. In each group, the first two subjects were randomly administered with sentries at a ratio of 1:1 between the test drug SSS55 and the placebo. The sentries were involved in blinding. After the sentries completed the safety assessment 8 days after administration, the remaining subjects in the group were administered in a random ratio between the test drug group and the placebo group.
- Conditions
- Safety Issues
- Being tested
- SSS55
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS55Drug
Also called SSS55 injection
SSS55 is an injection targeting complement C3b
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | dose1 Receives: Drug: SSS55 |
| middle-dose group | Experimental | dose 2 Receives: Drug: SSS55 |
| high-dose group | Experimental | dose 3 Receives: Drug: SSS55 |
| Higher-dose group | Experimental | dose 4 Receives: Drug: SSS55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 22days
Secondary outcomes (3)
To evaluate the pharmacokinetic (PK) characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the AUC of SSS55 injection
Measured: 22days
To evaluate the pharmacodynamic characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the complement3 of SSS55 injection
Measured: 22 days
To evaluate the ADA of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
To evaluate the ADA of SSS55 injection
Measured: 22days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start4 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical Co., LTD.The 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058779
- Sponsor's protocol ID
- SSS55-101
- Status last verified
- Feb 2026
- First submitted
- 26 May 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SSS55 Injection in Healthy Subjects in China
- ClinicalTrials.gov ID
- NCT07058779
- Acronym / sponsor ID
- SSS55-101
- Conditions
- Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jul 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 was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.
Detailed description
This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.In this trial, four dose groups were preset. The initial dose and dose level were relatively low. Two subjects were planned to be enrolled and only received SSS55 administration. In the subsequent dose group, sentries were set up in each group. In each group, the first two subjects were randomly administered with sentries at a ratio of 1:1 between the test drug SSS55 and the placebo. The sentries were involved in blinding. After the sentries completed the safety assessment 8 days after administration, the remaining subjects in the group were administered in a random ratio between the test drug group and the placebo group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: SSS55dose1 |
| middle-dose group | Experimental | Drug: SSS55dose 2 |
| high-dose group | Experimental | Drug: SSS55dose 3 |
| Higher-dose group | Experimental | Drug: SSS55dose 4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects aged 18 to 45 years old (including the boundary value), regardless of gender;
- The subjects voluntarily participated in the clinical trial and signed the informed consent form;
- Men with a weight of ≥50 kg, women with a weight of ≥45 kg, and those with a body mass index (BMI) ranging from 19 to 28 kg/m2 (including the critical value);
- Those who underwent vital sign assessment, physical examination, blood routine, urine routine, blood biochemistry, coagulation function, pregnancy examination (for women of childbearing age), 12-lead ECG, chest X-ray/lung CT during screening, and the results showed no abnormalities or the abnormalities had no clinical significance;
- Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization.
Key exclusion criteria (12 listed)
- 1) Those with a clear history of drug or food allergies, or a known history of hypersensitivity reactions that are clinically significant to the research intervention measures or related compounds or commonly used antibacterial agents;
- 2) Those with a history of any serious clinical diseases in the past or present, including but not limited to those in the digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, immune system, neuropsychiatric system, hematological system, etc. (except those deemed eligible for enrollment by the researcher);
- 3) First-degree relatives with a known history of meningococcal infection or a history of meningococcal infection;
- 4) Those with contraindications to meningococcal vaccination (with a history of epilepsy or other brain diseases, etc.);
- 5) There was or suspected active viral, bacterial, fungal or parasitic infection within 14 days prior to screening, including herpes, shingles or cold sores;
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 |
|---|---|---|
| SSS55Also: SSS55 injectionSSS55 is an injection targeting complement C3b | Drug | Higher-dose group, Low-dose group, high-dose group, middle-dose group |
Primary outcome
To evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China
Time frame: 22days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 secondary outcomes
To evaluate the pharmacokinetic (PK) characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
Time frame: 22days
To evaluate the pharmacodynamic characteristics of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
Time frame: 22 days
To evaluate the ADA of SSS55 injection after a single intravenous infusion in healthy adult subjects in China
Time frame: 22days
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 2 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSS55 in people with Safety Issues, run by Shenyang Sunshine Pharmaceutical Co., LTD. 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 12 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 2 Mar 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. 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?
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.
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 Ding Chief Pharmacist, Doctor of Medicine (86-13761642319, shiyiphase1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of a single intravenous infusion of SSS55 injection in healthy adult subjects in China (time frame: 22days). 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 2 Mar 2026.