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Also known as KB408 (Nebulization)
KB408 · 1 trial · 1 indication
Number of subjects with treatment related adverse events as assessed by NCI-CTCAE v5
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Low dose KB408 | EXPERIMENTAL | Single dose of KB408 (low dose) |
| Cohort 2: Mid dose KB408 | EXPERIMENTAL | Single dose of KB408 (mid dose) |
| Cohort 3: High dose KB408 | EXPERIMENTAL | Single dose of KB408 (high dose) |
| Cohort 2b: Mid dose KB408 | EXPERIMENTAL | Multiple doses of KB408 (mid dose) |
| Name | Type | Description |
|---|---|---|
| KB408 (Nebulization) | DRUG | Nebulized solution of KB408, a replication-defective HSV-1 vector expressing full length human SERPINA1 |
Inclusion Criteria: 1. The subject or legally authorized representative must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions. 2. Subject is aged ≥18 to ≤70 years, at th...
KB408 is an investigational therapy being developed for the treatment of Alpha 1-Antitrypsin Deficiency, a rare genetic condition. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is administered via nebulization and is being studied in a clinical trial in the United States.
KB408 targets the SERPINA1 gene, which encodes alpha-1 antitrypsin, a protein that protects the lungs and liver. By targeting SERPINA1, KB408 aims to address the underlying deficiency in patients with Alpha 1-Antitrypsin Deficiency. The therapy is designed for nebulized delivery to the lungs.
KB408 is being developed by Krystal Biotech, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KRYS. The company is conducting a Phase 1 clinical trial to evaluate KB408 for the treatment of Alpha 1-Antitrypsin Deficiency.
KB408 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively recruiting participants in the United States to study the safety and effects of KB408 in patients with Alpha 1-Antitrypsin Deficiency.
KB408 is being studied in a Phase 1 clinical trial with the identifier NCT06049082, titled "A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency." This trial is recruiting 15 participants aged 18 years and older in the United States. The study is controlled but not randomized or double-blinded.
Yes, KB408 is also known as KB408 (Nebulization), reflecting its method of administration. The drug is delivered via nebulization, which involves inhaling a mist. This alternative name is used in clinical contexts to specify the route of administration for the therapy.