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.
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).
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.
Parallel
SSS67 Injection
DrugIn this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
Placebo
DrugParticipants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.
6
Treatment groupsSee each treatment group below.
Incidence and severity of AEs
Peak concentration
Incidence of antidrug antibodies (ADAs) to SSS67 over time
Bone formation biomarker
bone resorption biomarker
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This trial is not recruiting at the moment. You can still explore other options:
