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New Immune-Targeting injection tested in healthy people for first time

NCT ID NCT07058779

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tests a single dose of SSS55 injection in 26 healthy adults in China. The main goal is to check if it is safe and how the body handles it. Researchers will also look at how it affects the immune system. This is a first step before testing it in people with diseases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SSS55 injection (targets complement C3b, a part of the immune system)
What this could lead to
If safe, this could pave the way for future studies of SSS55 in diseases where the immune system attacks the body, like certain autoimmune conditions.
What could go wrong
This is a very early Phase 1 trial in only 26 healthy people, so it cannot tell us if SSS55 works for any disease. Side effects are unknown and may occur.
Why investors are watching

3SBio Inc. is running an early-stage trial of SSS55 injection through its subsidiary Shenyang Sunshine Pharmaceutical. The trial tests the drug's safety, tolerability, and how the body processes it in 26 healthy volunteers in China. For a small company, this readout matters because it is the first check on whether the drug is safe enough to keep developing.

If it works: If the trial shows SSS55 injection is safe and well tolerated, 3SBio can move the drug into later-stage testing. That progress could strengthen the company's pipeline and support its value as a drug developer.

If it fails: The trial could reveal safety problems or poor tolerability, which would likely halt development of SSS55 injection. Early-stage trials fail often, and a negative result would remove a potential asset from 3SBio's pipeline.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy subjects aged 18 to 45 years old (including the boundary value), regardless of gender; 2. The subjects voluntarily participated in the clinical trial and signed the informed consent form; 3. 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); 4. 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; 5. Be willing to receive the MV-ACYW meningococcal vaccine and pneumococcal vaccine 14 days or more before randomization. Exclusion Criteria: * 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; 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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