Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Xiujuan Liu
- Phone Number: +86 15942305899
- Email: liuxiujuan1@3sbio.com
Study Locations
-
-
New South Wales
-
Charlestown, New South Wales, Australia, 2290
- Novatrials
-
Contact:
- Director Clinical
- Phone Number: +61 240893746
- Email: toni@novatrials.com.au
-
-
-
-
Hebei
-
Shijiazhuang, Hebei, China
- The First Hospital of Hebei Medical University
-
Contact:
- Chunhua Zhou
- Phone Number: +86 18633881377
- Email: zhouchunhua80@126.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
|
|
Experimental: SSS67 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.
|
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence and severity of AEs
Time Frame: Day 57
|
Day 57
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak concentration
Time Frame: Day 57
|
Day 57
|
|
Incidence of antidrug antibodies (ADAs) to SSS67 over time
Time Frame: Day 57
|
Day 57
|
|
Bone formation biomarker
Time Frame: Day 57
|
Day 57
|
|
bone resorption biomarker
Time Frame: Day 57
|
Day 57
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- SSS67-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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