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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07140081
Registration number
NCT07140081
Ethics application status
Date submitted
4/08/2025
Date registered
24/08/2025
Date last updated
24/08/2025
Titles & IDs
Public title
A Research Study to Evaluate BLX-0871 in Healthy Adults
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Scientific 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
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Secondary ID [1]
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BLX-0871-CLN-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Normal Healthy Adults
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BLX-0871
Treatment: Drugs - Placebo
Experimental: BLX-0871 Oral Dose - Participants will receive oral BLX-0871 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).
Placebo comparator: Placebo to match BLX-0871 - 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).
Treatment: Drugs: BLX-0871
BLX-0871 Single or Multiple doses administered orally as a tablet
Treatment: Drugs: Placebo
Participants will receive matching placebo of BLX-0871 for each of the oral cohorts.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants who experienced Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose through End of Study (up to ~28 days per participant)
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Primary outcome [2]
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Number of participants who experienced Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose through End of Study (up to ~28 days per participant)
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Primary outcome [3]
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Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose through End of Study (up to ~28 days per participant)
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Secondary outcome [1]
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Assess maximum observed drug concentration (Cmax)
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Assessment method [1]
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Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults
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Timepoint [1]
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Up to 14 days after last dose in each cohort
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Secondary outcome [2]
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Assess time to maximum concentration (Tmax)
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Assessment method [2]
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Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults
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Timepoint [2]
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Up to 14 days after last dose in each cohort
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Secondary outcome [3]
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Assess the area under the concentration-time curve from time 0 to infinity (AUCinf)
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Assessment method [3]
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Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults
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Timepoint [3]
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Up to 14 days after last dose in each cohort
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Secondary outcome [4]
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Assess the area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)
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Assessment method [4]
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Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults
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Timepoint [4]
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Up to 14 days after last dose in each cohort
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Secondary outcome [5]
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Assess half-life (t½) plasma concentration
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Assessment method [5]
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Evaluate the relative bioavailability of BLX-0871 in single, food effect, and multiple ascending doses in healthy adults
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Timepoint [5]
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Up to 14 days after last dose in each cohort
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Secondary outcome [6]
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Serum fructosamine
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Assessment method [6]
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Evaluate the effect of single and multiple oral doses of BLX-0871 on serum fructosamine levels
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Timepoint [6]
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Up to 14 days after last dose in each cohort
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Secondary outcome [7]
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Plasma levels of phosphorylated AMPK (pAMPK) and total AMPK
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Assessment method [7]
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Evaluate the effect of multiple oral doses of BLX-0871 on plasma levels of phosphorylated AMPK (pAMPK) and total AMPK
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Timepoint [7]
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Up to 14 days after last dose in each cohort
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Secondary outcome [8]
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Plasma levels of phosphorylated acetyl-CoA carboxylase ACC (pACC) and total ACC
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Assessment method [8]
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Evaluate the effect of multiple oral doses of BLX-0871 on plasma levels of levels of phosphorylated acetyl-CoA carboxylase ACC (pACC) and total ACC
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Timepoint [8]
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Up to 14 days after last dose in each cohort
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
76
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Nucleus Network St Kilda Road - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biolexis Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07140081
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jeremiah Bearss, MD, PhD
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Address
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Country
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Phone
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(385) 476-3080
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07140081
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