Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB-0669 · 1 trial · 1 indication
Participant incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: Clinical laboratory results (hematology, clinical chemistry, coagulation and urinalysis, vital signs, twelve-lead electrocardiograms (ECGs).
| Arm | Type | Description |
|---|---|---|
| Study Intervention GB-0669 | EXPERIMENTAL | Study intervention |
| Placebo | PLACEBO_COMPARATOR | sterile 0.9% (w/v) sodium chloride solution |
| Name | Type | Description |
|---|---|---|
| GB-0669 | DRUG | Single IV infusion of GB-0669. |
| Placebo | DRUG | Single IV infusion of placebo. Sterile 0.9% (w/v) sodium chloride solution. |
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects 2. Adults, 18 to 55 years of age (inclusive) at screening 3. Body...
GB-0669 is an investigational small molecule being studied for the treatment or prevention of SARS CoV-2, the virus that causes COVID-19. It is currently in Phase 1 clinical development, meaning it has not yet been approved for use and is still being evaluated for safety and tolerability in humans.
GB-0669 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol GENB. The drug is currently in Phase 1 clinical trials for SARS CoV-2.
GB-0669 is in Phase 1 clinical development. It is an investigational drug, meaning it 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 SARS CoV-2.
GB-0669 has one completed Phase 1 clinical trial, identified as NCT07050511. This study investigated the safety, tolerability, and pharmacokinetics of GB-0669 in healthy adult participants in the United States. The trial enrolled 51 participants and was placebo-controlled and double-blind.
GB-0669 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for SARS CoV-2. The completed Phase 1 trial focused on safety and tolerability in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.