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Debio 1453P · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Single ascending dose (SAD) | EXPERIMENTAL | Participants will receive a single oral dose of Debio 1453P or placebo in a sequential manner on Day 1. |
| Part 2: Multiple ascending dose (MAD) | EXPERIMENTAL | Participants will receive multiple oral doses of Debio 1453P or placebo from Day 1 to Day 5. Debio 1453P initial dose in this part will be based on available data from SAD part. |
| Name | Type | Description |
|---|---|---|
| Debio 1453P | DRUG | Powder for oral solution |
| Placebo | DRUG | Oral solution |
Inclusion Criteria 1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures. 2. Be within the age range of 18 to 55 years, inclusive, at the time of screening. 3. Have a body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2. Exclusion criteria 1. History and/...
Debio 1453P is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a first-in-human trial evaluating its safety, tolerability, and pharmacokinetics after single and multiple oral doses.
Debio 1453P is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting a Phase 1 trial of the drug in healthy adults.
Debio 1453P is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug's safety, tolerability, and pharmacokinetics.
Debio 1453P is being studied in one active Phase 1 clinical trial, registered as NCT07035769. This first-in-human study is evaluating the safety, tolerability, and pharmacokinetics of single and multiple oral doses of Debio 1453P in healthy adults. The trial is recruiting 88 participants in Belgium.
Yes, Debio 1453P is a small molecule drug. It is being developed as an oral formulation, as the clinical trial involves administering single and multiple oral doses to healthy participants.