Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-622 · 2 trials · 2 indications
Occurrence and incidence of Treatment-Emergent Adverse Events (TEAE) and serious adverse events during the study.
To evaluate the safety profile as determined by the incidence of adverse events in single or multiple ascending doses of CDX-622 or placebo comparator in healthy participants.
| Arm | Type | Description |
|---|---|---|
| CDX-622 | EXPERIMENTAL | Eligible participants will receive a single dose |
| Normal Saline | PLACEBO_COMPARATOR | Eligible participants will receive doses of Normal Saline by IV or SC |
| Name | Type | Description |
|---|---|---|
| CDX-622 | DRUG | Administered Intravenously |
| Normal Saline | DRUG | Up to 4 infusions or 6 SC injections of normal saline |
Key Inclusion Criteria: 1. Males and females, ≥ 18 years of age 2. Diagnosis of mild to moderate asthma for at least 12 months 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted normal 4. Airway reversibility ≥ 12% and 200 mL improvement in FEV1 5. Both males and f...
CDX-622 is an investigational small molecule being developed by Celldex Therapeutics for mild to moderate asthma. It is currently in Phase 1 clinical trials, including a completed study in healthy participants and an ongoing study in patients with mild to moderate asthma.
CDX-622 targets TSLP, a cytokine involved in inflammatory responses. By targeting TSLP, CDX-622 is being studied for its potential role in treating mild to moderate asthma.
CDX-622 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol CLDX. The company is conducting Phase 1 clinical trials for this investigational drug.
CDX-622 is in Phase 1 clinical development. It is not yet approved by the FDA and remains investigational. The drug is being studied in healthy participants and in patients with mild to moderate asthma.
CDX-622 is being studied in two Phase 1 trials. NCT06650761, a completed study in healthy participants with 85 enrolled, and NCT07330778, a recruiting study in patients with mild to moderate asthma with 12 participants. Both trials are randomized, double-blind, and placebo-controlled.
CDX-622 is a small molecule that targets TSLP, making it a TSLP inhibitor. However, it is a distinct investigational drug developed by Celldex Therapeutics and is not the same as other TSLP-targeting therapies.