First-in-Human (FIH) Trial

**What it means:** This is the **very first time a drug is given to people** — never humans before, only animals (and cell cultures). It's essentially Phase 1a. The goals are: 1. **Safety** — does the drug cause unexpected side effects in humans? 2. **Dose-finding** — what dose levels can people tolerate? 3. **Pharmacokinetics** — how does the human body process this drug? **Why it matters for MHS:** Alaw Therapeutics dosing their first patient in AL-605's FIH trial means we're moving closer to CDK2 inhibitors being available as a potential symptomatic treatment for MHS. AL-605 is specifically designed to cross the blood-brain barrier, which is critical for any MHS therapy. While currently in oncology trials, the mechanism (CDK2 inhibition) is directly relevant to the MEF2C-p21-CDK2 neuroinflammation pathway.