Health Trials

A Research Study to Evaluate BLX-0871 in Healthy Adults

ConditionNormal Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiolexis Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

Healthy males or females, 18-65 years, BMI 20-35 kilograms/meter² (kg/m²), weight ≥50 kilograms (kg).

Normal or clinically acceptable labs, vital signs

HbA1c <6.5%, non-fasting glucose 4.0-7.8 milimol/Liter (mmol/L)

Willing to follow contraception requirements, avoid alcohol, nicotine, and blood donation per protocol, and comply with all study visits and procedures.

Disqualifiers

History of diabetes, clinically significant cardiovascular, hepatic, renal, gastrointestinal, psychiatric, or neurologic disease, or abnormal labs/Echocardiograms (ECG) deemed clinically relevant.

Prior gastrointestinal (GI) surgery affecting absorption (e.g., gastric bypass) or chronic GI disorders.

History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 (MEN2); malignancy within 5 years (except treated basal cell or in situ cervical cancer).

History of severe allergic reactions, seizures, or psychiatric hospitalization; positive drug, alcohol, or cotinine test.

Trial design

Treatments tested in this trial

  • BLX-0871
  • Placebo

Treatment groups

76 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Nucleus Network St Kilda Road Status unavailable Melbourne, New South WalesAustraliaAustralia

Sponsors and collaborators

Biolexis Therapeutics

Lead sponsor

Source ClinicalTrials.gov