Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AST2818 · 2 trials · 1 indication
The percentage of radioactive dose of \[14C\] radiolabelled AST2818 recovered in blood and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
The percentage of radioactive dose of \[14C\] radiolabelled AST2818 recovered in urine, faeces and in total, up to Day 85（p.s:The administration time on the first day is 7:30 am）
The concentrations of AST2818 and AST5902 in plasma up to Day 85（p.s:The administration time on the first day is 7:30 am）
Proportion of different metabolites
Types of adverse events
Pharmacokinetics of AST2818 by assessment of maximum plasma AST2818 concentration.
Pharmacokinetics of AST2818 by assessment of area under the plasma concentration time curve from zero to appointed time
Pharmacokinetics of AST2818 by assessment of time to Cmax.
| Arm | Type | Description |
|---|---|---|
| [14C]-AST2818 80mg (oral solution) | EXPERIMENTAL | Volunteers will receive 80 mg \[14C\]-AST2818 containing a nominal 100 μCi activity, administered by mouth, as a solution. |
| Fasted AST2818 tablets following a period of fasting | EXPERIMENTAL | - |
| High-fat meal AST2818 tablets following a high-fat meal | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| [14]-AST2818 | DRUG | Volunteer will receive a single oral dose of 80 mg /100 u Ci \[14C\]-AST2818 as a solution on Day 1 |
| AST2818 Tablets | DRUG | AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. |
Inclusion Criteria: 1. Healthy adult; 2. Body weight: The body mass index varies in the range of 19 - 26 kg/m2 (including 19 and 26 kg/m2); 3. Signing the informed consent forms by oneself ; 4. Be able to communicate well with the researcher and be able to complete the trial in accordance with the ...
AST2818 is an investigational small molecule being studied in healthy male volunteers. It is currently in Phase 1 clinical development, with two completed trials in China. The drug is being evaluated for its blood levels and how it is processed by the body, but it is not yet approved for any medical condition.
AST2818 is being developed by ArriVent BioPharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AVBP. ArriVent is conducting early-stage clinical trials to evaluate the drug's pharmacokinetics and metabolism in healthy volunteers.
AST2818 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy male volunteers in China. These studies are designed to assess the drug's safety, tolerability, and how it is absorbed and eliminated by the body. The drug is not yet approved and remains investigational.
AST2818 has two completed Phase 1 clinical trials. NCT03926182 studied the effect of food on blood levels of AST2818 in 16 healthy male volunteers. NCT03941340 evaluated the mass balance and biotransformation of a single dose of [14C] AST2818 in 6 Chinese healthy male volunteers. Both trials were conducted in China.
AST2818 is the drug name used in clinical trials, and no alternative names have been reported. It is a small molecule being developed by ArriVent BioPharma. The drug is currently in early-stage testing and has not been approved for any use.