New drug SSS68 tested in healthy people for first time
NCT ID NCT07606976
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Huashan Hospital of Fudan University
Shanghai, 200000, China
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