Clinical trial

A Research Study to Evaluate BLX-7006 in Healthy Adults

Opening soon · Phase 1 · 1 countries · Registry ID NCT07140055

Opening soonPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionNormal Healthy Volunteer, Safety After Oral Intake

Full registry criteria

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. 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.

Treatments and study arms

BLX-7006

Drug

BLX-7006 Single or Multiple doses administered orally as a tablet

Placebo

Drug

Participants will receive matching placebo of BLX-7006 for each of the oral cohorts.

Primary outcomes

Number of participants who experienced Adverse Events (AEs)From first dose through End of Study (up to ~28 days per participant)

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.

Number of participants who experienced Serious Adverse Events (SAEs)From first dose through End of Study (up to ~28 days per participant)

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.

Number of participants who experienced Treatment-Related Adverse Avents (TRAEs)From first dose through End of Study (up to ~28 days per participant)

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nucleus Network Brisbane Clinic🇦🇺 Brisbane, Queensland, Australia
Study contactContact