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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSS67 Injection | Drug | In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration | Day 57 | |
| Incidence of antidrug antibodies (ADAs) to SSS67 over time | Day 57 | |
| Bone formation biomarker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiujuan Liu | Contact | +86 15942305899 | liuxiujuan1@3sbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novatrials | Charlestown | New South Wales | 2290 | Australia |
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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| 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. |
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| Placebo | Drug | Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group. |
|
| Day 57 |
| bone resorption biomarker | Day 57 |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
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