Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB-7624 · 1 trial · 1 indication
Participant incidence and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs),and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
Participant incidence and severity of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and TEAEs leading to discontinuation of study treatment. Clinically significant (CS) changes from baseline in: * Clinical laboratory results (haematology, clinical chemistry, coagulation and urinalysis) * Vital signs * Twelve-lead electrocardiograms (ECGs)
| Arm | Type | Description |
|---|---|---|
| Study intervention: GB-7624 | EXPERIMENTAL | - |
| Study Intervention: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GB-7624 | DRUG | Study Drug GB-7624 |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Participants must have given written informed consent before any trial-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 65 years of age (inclusive) at the...
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GB-7624 is an investigational small molecule being developed for the treatment of Atopic Dermatitis (AD). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy adult participants.
GB-7624 targets IL-13, a cytokine involved in inflammatory responses. By targeting IL-13, the drug aims to modulate pathways relevant to Atopic Dermatitis. This mechanism is being evaluated in early-stage clinical trials to assess its potential therapeutic effect.
GB-7624 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers as part of its Phase 1 development program.
GB-7624 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or other regulatory agencies. A Phase 1 study is currently active but not recruiting participants, focusing on safety, tolerability, and pharmacokinetics.
GB-7624 is being evaluated in a Phase 1 clinical trial with the identifier NCT06920693. This study is investigating the safety, tolerability, and pharmacokinetics of GB-7624 in healthy adult participants. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 40 participants in Australia.
GB-7624 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being studied under this designation in clinical trials for Atopic Dermatitis, and no other drug names have been associated with it in available data.