HealthyPhase 1NCT07487545
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
A Phase 1 study testing SSS67 Injection in people with Healthy, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, preliminary PD and immunogenicity of SSS67 in healthy adult participants after single intravenous infusion. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SSS67 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Mar 2026to 2 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 65 years (inclusive), regardless of gender.
- Participate in the clinical trial voluntarily and provide informed consent form.
- At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females. Body Mass Index (BMI) must be between 18.5 and 32 kg/m² (inclusive).
- At screening, the following must be within normal ranges or assessed by the investigator as abnormal but not clinically significant: Vital signs、Physical examination、12-lead electrocardiogram (ECG)、Chest X-ray (posteroanterior view) or lung computed tomography (CT)、Ultrasound (abdominal, urological, and gynecological [for females only])、Clinical laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation, serum virolgy and thyroid function).
- 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 last dose of investigational drug.
- Able to understand and comply with protocol requirements.
Who cannot join
- History of significant drug or food allergies; or known clinically significant hypersensitivity to the study intervention or related compounds.
- History of risk factors for torsades de pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia (one retest may be allowed per Investigator's judgment), or QT (QTcF) interval >450 ms.
- Any clinically significant medical condition or illness that could compromise participant safety or interfere with study results.
- History of any malignancy within the past 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ th with no evidence of metastatic disease for 3 years.
- Known concomitant conditions affecting skeletal muscle, or use of any medications or supplements known to influence muscle anabolism/catabolism within 3 months prior to screening.
- History of gastrointestinal surgery resulting in malabsorption, or chronic use of medications that s directly affect gastrointestinal motility. Examples: history of bariatric surgery/procedures (e.g., gastric banding), use of medications/products deemed by the investigator to cause weight change and affect weight assessment within 3 months prior to dosing, or intention to use weight-loss drugs during the study.
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- Use of any prescription drugs or over-the-counter medications, herbal medicines, or dietary supplements within 4 weeks prior to screening (participants may be enrolled if the investigator confirms the time interval between last use and the first dose in this trial is >5 half-lives of the drug).
- Use of drugs potentially affecting follicle-stimulating hormone (FSH) levels within 90 days prior to screening, or planned use during the study.
- Regular weightlifting, bodybuilding, or strength training aimed at increasing muscle mass.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site
Novatrials
Charlestown, New South Wales, 2290
Director Clinical, +61 240893746, toni@novatrials.com.au
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei
Chunhua Zhou, +86 18633881377, zhouchunhua80@126.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, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK, preliminary PD and immunogenicity of SSS67 in healthy adult participants after single intravenous infusion.
The primary objective is to assess the safety and tolerability of SSS67 following single ascending doses.
The secondary objectives are to characterize the PK, PD, and anti-drug antibody (ADA) profiles of SSS67 after single administration.
The exploratory objective is to evaluate changes in body weight, waist circumference, and other related metabolic parameters following a single dose of SSS67.
- Conditions
- Healthy
- Being tested
- SSS67 Injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS67 InjectionDrug
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
PlaceboDrug
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
| Study group | Role | What they receive |
|---|---|---|
| SSS67 1mg/kg | Experimental | This is a single-dose group. 2 participants will be enrolled and receive a single intravenous infusion of SSS67 at 1 mg/kg on Day 1. No placebo is administered in this group. Receives: Drug: SSS67 Injection |
| SSS67 5mg/kg+Placebo | Experimental | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 5 mg/kg on Day 1, and 2 receive matching placebo on Day 1. Receives: Drug: SSS67 Injection; Drug: Placebo |
| SSS67 15mg/kg+Placebo | Experimental | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 15 mg/kg on Day 1, and 2 receive matching placebo on Day 1. Receives: Drug: SSS67 Injection; Drug: Placebo |
| SSS67 30mg/kg+Placebo | Experimental | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 30 mg/kg on Day 1, and 2 receive matching placebo on Day 1. Receives: Drug: SSS67 Injection; Drug: Placebo |
| SSS67 45mg/kg+Placebo | Experimental | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 45 mg/kg on Day 1, and 2 receive matching placebo on Day 1. Receives: Drug: SSS67 Injection; Drug: Placebo |
| SSS67 60mg/kg+Placebo | Experimental | This is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 60 mg/kg on Day 1, and 2 receive matching placebo on Day 1. Receives: Drug: SSS67 Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs
Measured: Day 57
Secondary outcomes (4)
Peak concentration
Measured: Day 57
Incidence of antidrug antibodies (ADAs) to SSS67 over time
Measured: Day 57
Bone formation biomarker
Measured: Day 57
bone resorption biomarker
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion29 Aug 2026 (estimated)
- Study completion2 Apr 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 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
- NCT07487545
- Sponsor's protocol ID
- SSS67-101
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 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, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
- ClinicalTrials.gov ID
- NCT07487545
- Acronym / sponsor ID
- SSS67-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 2 Apr 2027 (estimated)
- First posted
- 23 Mar 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, preliminary PD and immunogenicity of SSS67 in healthy adult participants after single intravenous infusion.
The primary objective is to assess the safety and tolerability of SSS67 following single ascending doses.
The secondary objectives are to characterize the PK, PD, and anti-drug antibody (ADA) profiles of SSS67 after single administration.
The exploratory objective is to evaluate changes in body weight, waist circumference, and other related metabolic parameters following a single dose of SSS67.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SSS67 1mg/kg | Experimental | Drug: SSS67 InjectionThis is a single-dose group. 2 participants will be enrolled and receive a single intravenous infusion of SSS67 at 1 mg/kg on Day 1. No placebo is administered in this group. |
| SSS67 5mg/kg+Placebo | Experimental | Drug: SSS67 Injection, Drug: PlaceboThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 5 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 15mg/kg+Placebo | Experimental | Drug: SSS67 Injection, Drug: PlaceboThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 15 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 30mg/kg+Placebo | Experimental | Drug: SSS67 Injection, Drug: PlaceboThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 30 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 45mg/kg+Placebo | Experimental | Drug: SSS67 Injection, Drug: PlaceboThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 45 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
| SSS67 60mg/kg+Placebo | Experimental | Drug: SSS67 Injection, Drug: PlaceboThis is a single-dose group. 10 participants will be enrolled: 8 receive a single intravenous infusion of SSS67 at 60 mg/kg on Day 1, and 2 receive matching placebo on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18 to 65 years (inclusive), regardless of gender.
- Participate in the clinical trial voluntarily and provide informed consent form.
- At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females. Body Mass Index (BMI) must be between 18.5 and 32 kg/m² (inclusive).
- At screening, the following must be within normal ranges or assessed by the investigator as abnormal but not clinically significant: Vital signs、Physical examination、12-lead electrocardiogram (ECG)、Chest X-ray (posteroanterior view) or lung computed tomography (CT)、Ultrasound (abdominal, urological, and gynecological [for females only])、Clinical laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation, serum virolgy and thyroid function).
- 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 last dose of investigational drug.
Key exclusion criteria (9 listed)
- History of significant drug or food allergies; or known clinically significant hypersensitivity to the study intervention or related compounds.
- History of risk factors for torsades de pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia (one retest may be allowed per Investigator's judgment), or QT (QTcF) interval >450 ms.
- Any clinically significant medical condition or illness that could compromise participant safety or interfere with study results.
- History of any malignancy within the past 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ, or cervical carcinoma in situ th with no evidence of metastatic disease for 3 years.
- Known concomitant conditions affecting skeletal muscle, or use of any medications or supplements known to influence muscle anabolism/catabolism within 3 months prior to screening.
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 |
|---|---|---|
| SSS67 InjectionIn this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. | Drug | SSS67 15mg/kg+Placebo, SSS67 1mg/kg, SSS67 30mg/kg+Placebo, SSS67 45mg/kg+Placebo, SSS67 5mg/kg+Placebo, SSS67 60mg/kg+Placebo |
| PlaceboParticipants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. | Drug | SSS67 15mg/kg+Placebo, SSS67 30mg/kg+Placebo, SSS67 45mg/kg+Placebo, SSS67 5mg/kg+Placebo, SSS67 60mg/kg+Placebo |
Primary outcome
Incidence and severity of AEs
Time frame: Day 57
4 secondary outcomes
Peak concentration
Time frame: Day 57
Incidence of antidrug antibodies (ADAs) to SSS67 over time
Time frame: Day 57
Bone formation biomarker
Time frame: Day 57
bone resorption biomarker
Time frame: Day 57
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 23 Mar 2026.
- Individual participant dataSharing planned: No. Due to the nature of the study and privacy concerns, de-identified individual participant data will not be made available to external researchers.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SSS67 Injection in people with Healthy, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 2 sites in 2 countries.
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 9 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 23 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 2 sites in Australia, 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 Xiujuan Liu (+86 15942305899, liuxiujuan1@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs (time frame: Day 57). 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 23 Mar 2026.