Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D5884 · 1 trial · 1 indication
Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)
| Arm | Type | Description |
|---|---|---|
| D5884 | EXPERIMENTAL | D5884 capsule, Per oral(po) |
| Placebo | PLACEBO_COMPARATOR | Placebo capsule, po |
| Name | Type | Description |
|---|---|---|
| D5884 | DRUG | 1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian |
| Placebo | DRUG | 1. st cohort: Dose 1(2g) D5884(n=3) in Japanese 2. nd cohort: Dose 2(4g) D5884(n=3) in Japanese |
Inclusion Criteria: 1. Healthy adult male, 20 to 45 years of age (inclusive) 2. Body mass index (BMI) ≥18.5 and ≤25 kg/m2 for Japanese subjects, ≥18.5 and ≤30 kg/m2 for Caucasian subjects. BMI calculations to be conducted on height and weight values obtained at Visit 1 3. Medically healthy with cli...
D5884 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy male volunteers, and no therapeutic indication has been disclosed for the compound. It is not described as an approved medicine.
D5884 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 1 study of the compound conducted in Japan.
D5884 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no later-stage trials have been recorded. The compound is investigational and has not been described as approved by the FDA or any other regulator.
D5884 has been evaluated in one clinical trial, NCT02209766, titled a Phase 1 study in healthy male Japanese and Caucasian subjects after single and multiple doses of D5884 (omega-3-carboxylic acids). The trial was completed, enrolled 86 participants, was placebo controlled, and was conducted in Japan.
D5884 has been studied in healthy volunteers rather than in a patient population, and no disease indication has been disclosed for the compound. The completed Phase 1 trial, NCT02209766, enrolled healthy male participants in Japan to assess single and multiple doses.