A Research Study to Evaluate BLX-0871 in Healthy Adults

NCT07140081 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BLX-0871-CLN-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Healthy Adults

Keywords

BLX-0871; 0871; Obesity; Metabolic disorders; Normal health volunteer

Outcome Measures

Primary Outcomes (3)

• Number of participants who experienced Adverse Events (AEs)

  The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of adverse effects in subjects, as assessed according to CTCAE v5.0. The number of participants who experience an AE will be reported.

  From first dose through End of Study (up to ~28 days per participant)

• Number of participants who experienced Serious Adverse Events (SAEs)

  The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of SAE in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a SAE will be reported.

  From first dose through End of Study (up to ~28 days per participant)

• Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)

  The safety and tolerability of oral BLX-0871 administration will be evaluated based on the incidence of TRAEs in subjects, as assessed according to CTCAE v5.0. The number of participants who experience a TRAE will be reported.

  From first dose through End of Study (up to ~28 days per participant)

Secondary Outcomes (8)

• Assess maximum observed drug concentration (Cmax)

  Up to 14 days after last dose in each cohort

• Assess time to maximum concentration (Tmax)

  Up to 14 days after last dose in each cohort

• Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)

  Up to 14 days after last dose in each cohort

• Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)

  Up to 14 days after last dose in each cohort

• Assess half-life (t½) plasma concentration

  Up to 14 days after last dose in each cohort

Study Arms (2)

BLX-0871 Oral Dose

EXPERIMENTAL

Participants will receive oral BLX-0871 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).

Drug: BLX-0871

Placebo to match BLX-0871

PLACEBO COMPARATOR

Participants will receive an oral placebo that looks like BLX-0871 but does not contain active drug as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).

Drug: Placebo

Interventions

BLX-0871 DRUG

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

BLX-0871 Oral Dose

Placebo DRUG

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

Placebo to match BLX-0871

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of prescription drugs, Over the counter (OTC) /herbal supplements
• Participation in another clinical trial or blood donation within 30 days (or 5 half-lives of prior drug).
• Any condition or history that may compromise safety, study conduct, or compliance, in the opinion of the Investigator.

Sponsors & Collaborators

• Biolexis Therapeutics: lead

Study Sites (1)

Nucleus Network St Kilda Road

Melbourne, New South Wales, Australia

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jeremiah Bearss, MD, PhD

CONTACT

(385) 476-3080; jbearss@biolexistx.com

Matthew Anthony, BS, BS

CONTACT

(385) 476-3080

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)