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Humanized TNFα monoclonal antibody

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Sunshine Biopharma Inc.|Last Updated: Dec 27, 2017

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Humanized TNFα monoclonal antibody · 1 trial · 1 indication

Phase 1 1
NCT02460393A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy SubjectsRheumatoid Arthritis
COMPLETED72 Analytics
PHASE1COMPLETED
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC
28 days
Cmax
28 days
Cmin
28 days
Tmax
28 days

Secondary Endpoints

Serum creatinine and AST and ALT
28 days
or any other adverse events
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo groupPLACEBO_COMPARATORThe arm is as a control group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.
experimental groupEXPERIMENTALThe arm is as an experimental group to study the tolerance, safety and pharmacokinetic characteristics of Subcutaneous injection of different doses of humanized TNFα monoclonal antibody.

Interventions

NameTypeDescription
Humanized TNFα monoclonal antibodyDRUGSubcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people
placeboOTHERSubcutaneous injection of different doses for healthy people
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. healthy adult volunteers who are voluntary to participate in clinical trials, and signed the informed consent 2. aged 18-45 years, the same batch of subjects age difference is less than or equal to 10 years of age 3. subjects with qualified physical examination within 7 days ...

Countries:China
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Frequently asked questions about Humanized TNFα monoclonal antibody

What is Humanized TNFα monoclonal antibody used for?

Humanized TNFα monoclonal antibody is an investigational drug being studied for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated in a clinical trial involving healthy subjects to assess its safety and tolerability.

What does Humanized TNFα monoclonal antibody target?

Humanized TNFα monoclonal antibody targets tumor necrosis factor alpha (TNFα), a protein involved in inflammation. By binding to TNFα, the antibody is designed to neutralize its activity, which may help reduce the inflammatory processes associated with rheumatoid arthritis. This mechanism is being investigated in early-stage clinical trials.

Who makes Humanized TNFα monoclonal antibody?

Humanized TNFα monoclonal antibody is being developed by Sunshine Biopharma Inc., a biopharmaceutical company. The company is conducting clinical research on this drug candidate for rheumatoid arthritis. Sunshine Biopharma Inc. is publicly traded under the ticker symbol SBFM.

What phase is Humanized TNFα monoclonal antibody in?

Humanized TNFα monoclonal antibody is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for rheumatoid arthritis.

What clinical trials is Humanized TNFα monoclonal antibody in?

Humanized TNFα monoclonal antibody has one completed clinical trial registered as NCT02460393. This Phase 1 study evaluated single doses and dose escalation of the drug in healthy subjects in China. The trial enrolled 72 participants and was randomized, double-blind, and placebo-controlled.

Is Humanized TNFα monoclonal antibody the same as adalimumab?

Humanized TNFα monoclonal antibody is not the same as adalimumab. While both target TNFα, they are distinct drug candidates. The specific identity of this antibody is not provided, and it is being developed by Sunshine Biopharma Inc. under its own clinical program for rheumatoid arthritis.