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NOT YET RECRUITING
NCT07140081
PHASE1

A Research Study to Evaluate BLX-0871 in Healthy Adults

Sponsor: Biolexis Therapeutics

View on ClinicalTrials.gov

Summary

This study will test an oral medicine called BLX-0871, which is being developed to improve metabolic health by activating AMP-activated protein kinase (AMPK), a key regulator of energy balance. The main goal is to see if BLX-0871 is safe and well tolerated when given to healthy adults. The study will also measure how the body processes BLX-0871, including how quickly it is absorbed, how long it stays in the blood, and how it is eliminated. Another objective is to see whether food affects the absorption of BLX-0871. It will also look at how the drug affects the body by looking at markers of AMPK activity.

Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled Single-ascending Dose and Multiple-ascending Dose (SAD and MAD) Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Isoform-specific AMPK Activator BLX-0871 in Healthy Adults With a Body Mass Index (BMI) of 20 - 35 kg/m2

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2025-09

Completion Date

2026-05

Last Updated

2025-08-24

Healthy Volunteers

Yes

Interventions

DRUG

BLX-0871

BLX-0871 Single or Multiple doses administered orally as a tablet

DRUG

Placebo

Participants will receive matching placebo of BLX-0871 for each of the oral cohorts.

Locations (1)

Nucleus Network St Kilda Road

Melbourne, New South Wales, Australia