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Humanized TNFα monoclonal antibody · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo group | PLACEBO_COMPARATOR | The 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 group | EXPERIMENTAL | The 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. |
| Name | Type | Description |
|---|---|---|
| Humanized TNFα monoclonal antibody | DRUG | Subcutaneous injection of different doses for healthy people Subcutaneous injection of different doses in healthy people |
| placebo | OTHER | Subcutaneous injection of different doses for healthy people |
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 ...
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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.
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.
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.
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.
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.
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.