New drug SSS68 tested in healthy people for first time

NCT ID NCT07606976

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial will test the safety of a single dose of SSS68 in 50 healthy adults aged 18-45. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and how the drug moves through the body. The study is not yet recruiting and does not aim to treat any disease.

What this could mean

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

Active substance
SSS68
What could go wrong
This is a very early phase 1 study in healthy people, so it cannot show if SSS68 works for any disease. The main goal is just safety, not treatment.
Why investors are watching

3SBio Inc. is watching a Phase 1 trial run by its subsidiary, Shenyang Sunshine Pharmaceutical, that tests a single dose of the experimental drug SSS68 in 50 healthy adults. The trial checks whether the drug is safe, tolerable, and how the body processes it, which is a first major checkpoint for any new medicine. For a small company, this early readout matters because it can signal whether SSS68 is worth further investment or should be abandoned.

If it works: If the trial shows SSS68 is safe and well tolerated, 3SBio could move the drug into later-stage studies, which may expand its pipeline and attract partnership interest. A positive result would validate the company's research efforts and support continued development.

If it fails: Phase 1 trials often fail because the drug proves unsafe or poorly tolerated, which would likely end SSS68's development and waste the resources spent on it. A delay or unclear result could also slow the company's progress and raise doubts about its 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 50 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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. Able to understand and comply with protocol requirements, voluntarily participate in the trial and sign a written informed consent form (ICF). 2. Male or female participants aged 18-45 years (inclusive) when signing the ICF. 3. Male participants with body weight ≥ 50 kg, and female participants with body weight ≥ 45 kg. 4. Participants whose vital signs, physical examination results, laboratory test results, 12-lead electrocardiogram (ECG) and other test results are normal, or abnormal without clinical significance as determined by the investigator. 5. IgG/IgM/IgA \> upper limit of normal value at the screening Visit. 6. Female participants with childbearing potential and male participants (and their female partners) must agree to take highly effective contraceptive measures and have no plan of childbearing, sperm donation, or egg donation from screening through at least 6 months after the dose of study drug. Exclusion Criteria: 1. History of severe allergy, or with a history of allergy to the investigational drug, any of its components, or related excipients. 2. With any clinically significant diseases (including but not limited to gastrointestinal, hepatic, renal, neurological, hematological, endocrine, tumor, pulmonary, immunological, psychiatric, or cardiovascular diseases) prior to the screening visit. 3. Had any confirmed or suspected immunosuppressive or immune-deficient condition, including but not limited to history of opportunistic infections, asplenia, or primary immunodeficiency. 4. History of recurrent or chronic infections, or any infection requiring hospitalization or intravenous antiviral/antibiotic treatment within 6 months before dosing. 5. Participants with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody. 6. Participants who have undergone major surgery within 6 months before dosing, or plan to undergo major surgery during the study. 7. Participants who have received any marketed or investigational biological agent within 5 half-lives or 12 weeks (whichever is longer) before dosing. 8. Participants who have used any prescription drugs, over-the-counter medications, vitamin supplements, or herbal products within 4 weeks or 5 half-lives (whichever is longer) before dosing. 9. Participants who smoke more than 5 cigarettes per day within 3 months prior to screening. 10. History of significant alcohol abuse or regular use of alcohol within 6 months prior to the screening visit. 11. History of significant drug abuse, or any use of soft drugs within 3 months prior to screening, or any use of hard drugs within 1 year prior to screening, or positive result for urine drug screen test at screening. 12. Participants who have been vaccinated with live or live-attenuated vaccines within 30 days before dosing, or plan to receive vaccination during the study. 13. Participation in another interventional clinical trial within 3 months prior to screening. 14. Participants who have donated blood (≥ 400 mL) or lost a lot of blood (≥ 400 mL) within 3 months before screening. 15. QTcF ≥450 ms at the screening visit. 16. Participants who have other factors making participation in this trial inappropriate, as judged by the investigator.

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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

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Contacts and locations

Locations

  • Huashan Hospital of Fudan University

    Shanghai, 200000, China

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