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Azelaprag

Phase 1

Undisclosed | Small molecule | Other |BioAge Labs, Inc.|Trials Updated: Feb 23, 2024

Azelaprag development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2023

Azelaprag target and mechanism

ModalitySmall molecule

Also known as BGE-105

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Azelaprag clinical trials

Azelaprag · 1 trial · 1 indication

Phase 1 1
NCT06141889Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy VolunteersHealthy Volunteer Study
COMPLETED16 Analytics
PHASE1COMPLETED
Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers
Healthy Volunteer StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-t
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, area under the curve (AUC) from time 0 to time of the last observed serum concentration (AUC0-t)

Pharmacokinetics of azelaprag (BGE-105) after multiple-dose (Part 2) - AUC0-24
Study Part 2, Predose and post dose to 24 hours after the final dose is received.

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)

Pharmacokinetics of azelaprag (BGE-105) after oral administration - AUC0-inf
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, UAC from time 0 to infinity (AUC0-inf)

Pharmacokinetics of azelaprag (BGE-105) after oral administration - Cmax
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, maximum observed serum concentration (Cmax)

Pharmacokinetics of azelaprag (BGE-105) after oral administration - Tmax
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, time to reach Cmax (Tmax)

Pharmacokinetics of azelaprag (BGE-105) after oral administration - T1/2
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, terminal elimination half-life (T1/2)

Oral bioavailability of azelaprag after oral administration - Total body clearance
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, Total body clearance (CL)

Oral bioavailability of azelaprag after oral administration - Volume of distribution
Study Part 1, Predose and post dose to 144 hours after each dose received; Study Part 2, Predose and post dose to 96 hours after the final dose is received.

Assessment of PK parameter, volume of distribution (Vz)

Secondary Endpoints

Safety of azelaprag after oral administration - TEAEs
First dose to Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2EXPERIMENTALStudy 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

Interventions

NameTypeDescription
AzelapragDRUGoral, apelin receptor (APJ) agonist
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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....

Countries:New Zealand
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Frequently asked questions about Azelaprag

What is Azelaprag?

Azelaprag is an investigational small molecule developed by BioAge Labs, Inc. (ticker BIOA). It is in Phase 1 clinical development and has been studied in healthy older adult volunteers. Its therapeutic indications have not been disclosed.

Who is developing Azelaprag?

Azelaprag is being developed by BioAge Labs, Inc., which trades under the ticker BIOA. The company has completed a Phase 1 pharmacokinetics study of the drug in older adult healthy volunteers.

What phase is Azelaprag in?

Azelaprag is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA.

What clinical trials is Azelaprag in?

Azelaprag has been evaluated in one completed Phase 1 trial, NCT06141889, titled Pharmacokinetics Study of Azelaprag (BGE-105) in Older Adult Healthy Volunteers. The trial enrolled 16 participants aged 60 years and older in New Zealand.

Is Azelaprag the same as BGE-105?

Yes, Azelaprag is also known as BGE-105. The completed Phase 1 pharmacokinetics trial is listed under the name Azelaprag (BGE-105), so both names refer to the same investigational small molecule developed by BioAge Labs, Inc.