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 the ongoing study is evaluating its safety, tolerability, and pharmacokinetics in healthy adult participants. GB-7624 is not yet approved and remains in clinical investigation.
GB-7624 is being developed by Generate Biomedicines, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial of GB-7624 for Atopic Dermatitis. Generate Biomedicines is responsible for the research and development of this investigational small molecule therapy.
GB-7624 is in Phase 1 clinical development. The ongoing Phase 1 study is designed to investigate the safety, tolerability, and pharmacokinetics of GB-7624 in healthy adult participants. This is an early-stage clinical trial, and GB-7624 is not yet approved for any use.
GB-7624 is being studied in one active Phase 1 clinical trial, identified as NCT06920693. This trial is titled 'Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-7624 in Healthy Adult Participants.' It is a randomized, double-blind, placebo-controlled study with an enrollment of 40 participants, conducted in Australia.
GB-7624 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Atopic Dermatitis. The ongoing clinical trial is focused on assessing safety, tolerability, and pharmacokinetics in healthy volunteers. GB-7624 has not completed clinical development or received regulatory approval.