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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07140055
Registration number
NCT07140055
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-7006 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 Novel Glucagon-like Peptide-1 Receptor Agonist (GLP-1RA) BLX-7006 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-7006-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 Volunteer
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Safety After Oral Intake
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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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Diabetes
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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-7006
Treatment: Drugs - Placebo
Experimental: BLX-7006 Oral Dose - Participants will receive oral BLX-7006 as a single dose (in Part 1 or 2) or once daily for 7 days (in Part 3).
Placebo comparator: Placebo to match BLX-7006 - Participants will receive an oral placebo that looks like BLX-7006 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-7006
BLX-7006 Single or Multiple doses administered orally as a tablet
Treatment: Drugs: Placebo
Participants will receive matching placebo of BLX-7006 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-7006 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-7006 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-7006 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-7006 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-7006 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-7006 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-7006 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-7006 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 levels
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Assessment method [6]
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Evaluate the effect of single and multiple oral doses of BLX-7006 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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Insulin levels
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Assessment method [7]
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Evaluate the effect of single and multiple oral doses of BLX-7006 on insulin levels
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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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C-peptide levels
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Assessment method [8]
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Evaluate the effect of single and multiple oral doses of BLX-7006 on C-peptide levels
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Timepoint [8]
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Up to 14 days after last dose in each cohort
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Secondary outcome [9]
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Glucagon levels
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Assessment method [9]
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Evaluate the effect of single and multiple oral doses of BLX-7006 on glucagon levels
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Timepoint [9]
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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)
QLD
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Recruitment hospital [1]
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Nucleus Network Brisbane Clinic - Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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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-7006, which acts like the hormone Glucagon-like Peptide-1 (GLP-1) to help control blood sugar and body weight. Current GLP-1 medicines are given by injection. This study will see if BLX-7006 is safe, how the body processes it, and whether food changes how it is absorbed. The main goal is to see if BLX-7006 is safe and well tolerated. Secondary objectives of the study will measure how BLX-7006 moves through the body after an oral dose, including how quickly it is absorbed, how long it stays in the blood, and how the body removes it. It will also look at how the drug affects the body by looking at markers of glucose metabolism.
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Trial website
https://clinicaltrials.gov/study/NCT07140055
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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 James 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/NCT07140055
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