HealthyPhase 1NCT07606976
A Study of SSS68 Following a Single Subcutaneous Administration in Healthy Adult Participants
A Phase 1 study testing SSS68 in people with Healthy, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of SSS68 in healthy adult participants following a single subcutaneous administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SSS68
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Dec 2026
- 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
- Able to understand and comply with protocol requirements, voluntarily participate in the trial and sign a written informed consent form (ICF).
- Male or female participants aged 18-45 years (inclusive) when signing the ICF.
- Male participants with body weight ≥ 50 kg, and female participants with body weight ≥ 45 kg.
- 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.
- IgG/IgM/IgA > upper limit of normal value at the screening Visit.
- 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.
Who cannot join
- History of severe allergy, or with a history of allergy to the investigational drug, any of its components, or related excipients.
- 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.
- Had any confirmed or suspected immunosuppressive or immune-deficient condition, including but not limited to history of opportunistic infections, asplenia, or primary immunodeficiency.
- History of recurrent or chronic infections, or any infection requiring hospitalization or intravenous antiviral/antibiotic treatment within 6 months before dosing.
- Participants with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
- Participants who have undergone major surgery within 6 months before dosing, or plan to undergo major surgery during the study.
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- Participants who have received any marketed or investigational biological agent within 5 half-lives or 12 weeks (whichever is longer) before dosing.
- 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.
- Participants who smoke more than 5 cigarettes per day within 3 months prior to screening.
- History of significant alcohol abuse or regular use of alcohol within 6 months prior to the screening visit.
- 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.
- Participants who have been vaccinated with live or live-attenuated vaccines within 30 days before dosing, or plan to receive vaccination during the study.
- Participation in another interventional clinical trial within 3 months prior to screening.
- Participants who have donated blood (≥ 400 mL) or lost a lot of blood (≥ 400 mL) within 3 months before screening.
- QTcF ≥450 ms at the screening visit.
- Participants who have other factors making participation in this trial inappropriate, as judged by the investigator.
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
Huashan Hospital of Fudan University
Shanghai, 200000
Jing Zhang, +86 13816357098, zhangj_fudan@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamic and Immunogenicity of SSS68 Following a Single Subcutaneous Administration in Healthy Adult Participants
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of SSS68 in healthy adult participants following a single subcutaneous administration.
Read the detailed description
This is the first-in-human (FIH) clinical study of SSS68. Seven dose groups are planned for dose escalation in this study: 2 mg, 50 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg. The study will be conducted sequentially from low dose to high dose. Participants in all dose groups will receive a single subcutaneous injection.
The study consists of a screening period (no more than 4 weeks), a single-dose administration period (Day1), and a follow-up period (Day2 to Day113), with duration of approximately 20 weeks.
- Conditions
- Healthy
- Being tested
- SSS68, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS68Drug
A single dose of SSS68 will be administered SC on Day 1.
PlaceboDrug
A single dose of placebo will be administered SC on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| SSS68 | Experimental | SSS68 at doses ranging from 2 mg up to 1200 mg Receives: Drug: SSS68 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Summary of Treatment Emergent Adverse Events
The number of adverse events (AEs), serious adverse events (SAEs), and drug related adverse events following administration of SSS68.
Measured: Baseline to day 113
Secondary outcomes (8)
Maximum Observed Serum Concentration (Cmax)
The Cmax is the maximum observed serum concentration.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Time to Reach Maximum Observed Serum Concentration (Tmax)
The Tmax is the time correspondent to the maximum observed serum concentration.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Terminal half-life (t1/2)
The t1/2 is the time measured for the serum concentration to decrease by 1 half to its original concentration.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])
The AUC(0-t) is the area under the serum concentration-time curve from time 0 to last quantifiable concentration.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-inf])
The AUC(0-inf) is the area under the serum concentration-time curve from time zero to infinite time.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Apparent Total Systemic Clearance (CL/F)
The CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz/F after subcutaneous dose is influenced by the fraction absorbed.
Measured: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Immunogenicity
The number of participants with antibodies to SSS68.
Measured: Day 0, 15, 29, 57, and 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT07606976
- Sponsor's protocol ID
- SSS68-101
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamic and Immunogenicity of SSS68 Following a Single Subcutaneous Administration in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07606976
- Acronym / sponsor ID
- SSS68-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 May 2026 (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 is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of SSS68 in healthy adult participants following a single subcutaneous administration.
Detailed description
This is the first-in-human (FIH) clinical study of SSS68. Seven dose groups are planned for dose escalation in this study: 2 mg, 50 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg. The study will be conducted sequentially from low dose to high dose. Participants in all dose groups will receive a single subcutaneous injection.
The study consists of a screening period (no more than 4 weeks), a single-dose administration period (Day1), and a follow-up period (Day2 to Day113), with duration of approximately 20 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSS68 | Experimental | Drug: SSS68SSS68 at doses ranging from 2 mg up to 1200 mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand and comply with protocol requirements, voluntarily participate in the trial and sign a written informed consent form (ICF).
- Male or female participants aged 18-45 years (inclusive) when signing the ICF.
- Male participants with body weight ≥ 50 kg, and female participants with body weight ≥ 45 kg.
- 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.
- IgG/IgM/IgA > upper limit of normal value at the screening Visit.
Key exclusion criteria (16 listed)
- History of severe allergy, or with a history of allergy to the investigational drug, any of its components, or related excipients.
- 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.
- Had any confirmed or suspected immunosuppressive or immune-deficient condition, including but not limited to history of opportunistic infections, asplenia, or primary immunodeficiency.
- History of recurrent or chronic infections, or any infection requiring hospitalization or intravenous antiviral/antibiotic treatment within 6 months before dosing.
- Participants with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
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 |
|---|---|---|
| SSS68A single dose of SSS68 will be administered SC on Day 1. | Drug | SSS68 |
| PlaceboA single dose of placebo will be administered SC on Day 1. | Drug | Placebo |
Primary outcome
Overall Summary of Treatment Emergent Adverse Events
Time frame: Baseline to day 113
The number of adverse events (AEs), serious adverse events (SAEs), and drug related adverse events following administration of SSS68.
8 secondary outcomes
Maximum Observed Serum Concentration (Cmax)
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Terminal half-life (t1/2)
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-t])
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-inf])
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Apparent Total Systemic Clearance (CL/F)
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Apparent Volume of Distribution (Vz/F)
Time frame: 0, 2, 6, and 12 hours post-dose, Day 2, 3, 4, 6, 8, 15, 22, 29, 43, 57, 85, and 113
Immunogenicity
Time frame: Day 0, 15, 29, 57, and 113
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 26 May 2026.
- 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.
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 SSS68 in people with Healthy, 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 6 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 May 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. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Summary of Treatment Emergent Adverse Events (time frame: Baseline to day 113). 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 26 May 2026.