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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion Phase 1 52 Randomized Double-Blind Placebo-Controlled Single Dose
Clinical Trial NCT07487545 is designed to study Treatment for Healthy. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 31 March 2026 until the study accrues 52 participants. Led by Shenyang Sunshine Pharmaceutical Co., LTD., this study is expected to complete by 2 April 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
Brief 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.
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 ...
Show MoreOfficial 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
Conditions
HealthyOther Study IDs
- SSS67-101
NCT ID Number
Start Date (Actual)
2026-03-31
Last Update Posted
2026-03-23
Completion Date (Estimated)
2027-04-02
Enrollment (Estimated)
52
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSSS67 1mg/kg 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. |
ExperimentalSSS67 5mg/kg+Placebo 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. Placebo Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
ExperimentalSSS67 15mg/kg+Placebo 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. Placebo Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
ExperimentalSSS67 30mg/kg+Placebo 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. Placebo Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
ExperimentalSSS67 45mg/kg+Placebo 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. Placebo Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
ExperimentalSSS67 60mg/kg+Placebo 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. | SSS67 Injection In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. Placebo Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence and severity of AEs | Day 57 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Peak concentration | Day 57 | |
Incidence of antidrug antibodies (ADAs) to SSS67 over time | Day 57 | |
Bone formation biomarker | Day 57 | |
bone resorption biomarker | Day 57 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
- 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.
Shenyang Sunshine Pharmaceutical Co., LTD.Study Central Contact
Contact: Xiujuan Liu, +86 15942305899, [email protected]
2 Study Locations in 2 Countries
New South Wales
Novatrials, Charlestown, New South Wales, 2290, Australia
Director Clinical, Contact, +61 240893746, [email protected]
Hebei
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Chunhua Zhou, Contact, +86 18633881377, [email protected]