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Evaluate the Safety and Tolerability of SCT650C in Healthy Volunteers
The goal of clinical trial is to evaluate the safety and tolerability of SCT650C in healthy participants.
Study details:
Interleukin-17A (IL-17A) is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - systemic lupus erythematosus (SLE) and multiple sclerosis (MS). SCT650C is a novel humanized monoclonal antibody against human IL-17A developed by Sinocelltech which is now on the first step of clinical evaluation. SCT650C-612-1-01 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics and immunogenicity of SCT650C in healthy volunteers.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-06-01
Primary completion: 2023-11-01
Study completion finish: 2024-03-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05894707
Intervention or treatment
DRUG: SCT650C
Conditions
- • Autoimmune Disease
Find a site
Closest Location:
Linear Clinical Research - Joonadalup
Research sites nearby
Select from list below to view details:
Linear Clinical Research - Joonadalup
Joondalup, Western Australia, Australia
Linear Clinical Research - B Block
Nedlands, Western Australia, Australia
Linear Clinical Research - Harry Perkins
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: 80 mg SCT650C or normal saline
| DRUG: SCT650C
|
EXPERIMENTAL: 160 mg SCT650C or normal saline
| DRUG: SCT650C
|
EXPERIMENTAL: 40 mg SCT650C or normal saline
| DRUG: SCT650C
|
EXPERIMENTAL: 20 mg SCT650C or normal saline
| DRUG: SCT650C
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Baseline (Day 1, IP administration) up to 24 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of participants with at least one treatment-emergent serious adverse event (SAE) | An SAE is any AE that fulfills one or more of the following: * Results in death; * Is life-threatening; * Requires hospitalization or prolongation of existing hospitalization; * Results in persistent or significant disability or incapacity; * Results in a congenital abnormality or birth defect; * Important medical event | Baseline (Day 1, IP administration) up to 24 weeks |
Peak Plasma Concentration (Cmax) of SCT650C | Pharmacokinetics: Cmax is the maximum observed concentration of SCT650C into serum. | Baseline (Day -1 predose) up to 24 weeks |
Area under the plasma concentration versus time curve (AUC) of SCT650C | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported. | Baseline (Day -1 predose) up to 24 weeks |
The level of anti-drug antibodies (ADA) to SCT650C | Immunogenicity as measured by anti-drug antibodies (ADA) to SCT650C over time | Baseline (Day -1 predose) up to 24 weeks |
Frequently Asked Questions
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