Status:
COMPLETED
A First-in-Human Study Evaluating AGA2118 in Men and Postmenopausal Women
Lead Sponsor:
Angitia Biopharmaceuticals
Collaborating Sponsors:
Angitia Australia Pty Ltd
Conditions:
Osteoporosis
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
Brief Summary
The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy men and postmenopausal women and to assess t...
Detailed Description
This is a Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Absolute Bioavailability, Pharmacokinetics, and Pharmaco...
Eligibility Criteria
Inclusion
- Healthy men ≥ 30 and ≤ 65 years of age or postmenopausal women ≥ 45 and ≤ 65 years of age for SAD and MAD;
- BMI ≥ 18.5 and ≤ 32 kg/m\^2 (for SAD and MAD).
- Generally healthy (as assessed by the investigator).
- Nonsmokers, or light smokers, defined as ≤ 3 cigarettes/day (or equivalent) (for SAD and MAD).
- Able and willing to correctly and independently complete all study procedures and able to read, understand, and provide written informed consent after the nature of the study has been fully explained and must be willing to comply with all study requirements and procedures (for SAD and MAD).
- A male who is sterile or agrees to the following during the Treatment Period and for at least 6 months after the final dose of investigational product
- Refrain from donating fresh unwashed semen
- Plus, either
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
- OR
- Must agree to use contraception as detailed below
- Agree to use a male condom plus a female partner to use a highly effective method of contraception with a woman of childbearing potential who is not currently pregnant
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person
Exclusion
- A bone fracture within 6 months (for SAD only).
- Previous exposure to AGA2118 (for MAD only).
- Any condition that would affect bone metabolism or has a history of low energy fractures as documented in medical history (for MAD only).
- Administration of the any medications that known to affect bone metabolism within 6 months of Day 1 unless otherwise specified (for SAD and MAD).
- Human immunodeficiency virus (HIV) infection (for SAD and MAD).
- Active chronic hepatitis B (HBV) or hepatitis C (HCV) infection including hepatitis B surface antigen and hepatitis C antigen positive participants with or without abnormal liver enzymes (for SAD and MAD).
- Evidence of any of the following (for SAD and MAD):
- creatinine ≥ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at screening
- current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range
- known intolerance to calcium supplements
- malignancy within the last 5 years, etc.
Key Trial Info
Start Date :
June 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2024
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05225857
Start Date
June 28 2022
End Date
January 13 2024
Last Update
February 5 2024
Active Locations (2)
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1
Q-Pharm Pty Ltd
Brisbane, Queensland, Australia, 4006
2
Nucleus Network Pty Ltd.
Melbourne, Victoria, Australia, 3004