Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azelaprag · 1 trial · 1 indication
Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)
Assessment of PK parameter, area under the curve (AUC) over the dosing interval from time 0 to 24 hours following the final dose (AUC0-24)
Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)
Assessment of PK parameter, maximum observed serum concentration (Cmax)
Assessment of PK parameter, time to reach Cmax (Tmax)
Assessment of PK parameter, terminal elimination half-life (T1/2)
Assessment of PK parameter, Total body clearance (CL)
Assessment of PK parameter, volume of distribution (Vz)
| Arm | Type | Description |
|---|---|---|
| Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2 | EXPERIMENTAL | Study Part 1: Participants will receive a single Dose A or B on Day 1 and then followed by a crossover to a single Dose B or A on Day 8. Study Part 2: Participants in Study Part 2 will receive either a single Dose C or equivalent of Dose C administered twice daily, starting on Day 1 and through Day 14 |
| Name | Type | Description |
|---|---|---|
| Azelaprag | DRUG | oral, apelin receptor (APJ) agonist |
Key Inclusion Criteria: Patients who meet ALL the following inclusion criteria will be eligible to participate in the study: 1. Healthy male or female volunteers ≥ 60 years of age 2. No history or evidence of clinically relevant medical disorders 3. Body mass index (BMI) between 18 and 40 kg/m2 4....
Azelaprag is an investigational small molecule being studied in older adult healthy volunteers. It is being evaluated in a pharmacokinetics study to assess how the drug is processed in the body. The drug is currently in Phase 1 clinical development and is not approved for any indication.
Azelaprag is being developed by BioAge Labs, Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol BIOA. BioAge Labs is conducting clinical trials to evaluate the safety and pharmacokinetics of Azelaprag in older adult healthy volunteers.
Azelaprag is in Phase 1 clinical development. The drug is being studied in a completed Phase 1 trial that enrolled 16 older adult healthy volunteers. As an investigational drug, Azelaprag has not been approved by regulatory authorities and remains in early-stage clinical testing.
Azelaprag has one completed clinical trial, registered as NCT06141889. This Phase 1 study, titled "Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers," enrolled 16 participants in New Zealand. The trial was uncontrolled and not double-blinded, and it included healthy volunteers aged 60 years and older.
Yes, Azelaprag is also known as BGE-105. The clinical trial NCT06141889 refers to the drug as Azelaprag (BGE-105), confirming that both names identify the same investigational compound. This alternative name may be used in scientific literature and regulatory documents.