Status:
NOT_YET_RECRUITING
A Research Study to Evaluate BLX-7006 in Healthy Adults
Lead Sponsor:
Biolexis Therapeutics
Conditions:
Normal Healthy Volunteer
Safety After Oral Intake
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 inj...
Detailed Description
This is a Phase 1, single-center, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the effect of food on the PK of BLX-7006, a nove...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT07140055
Start Date
September 1 2025
End Date
May 1 2026
Last Update
August 24 2025
Active Locations (1)
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1
Nucleus Network Brisbane Clinic
Brisbane, Queensland, Australia