A First-in-Human Study Evaluating AGA2118 in Postmenopausal Women

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy postmenopausal women and to assess the safety and tolerability of AGA2118 after multiple subcutaneous administrations in postmenopausal women with low bone mass.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Angitia Biopharmaceuticals
• Collaborator: Angitia Australia Pty Ltd

Criteria

Inclusion Criteria:

1. Healthy postmenopausal women between 45 and 64 years of age for SAD; postmenopausal women between 45 to 80 years of age for MAD;

2. BMI ≥ 18.5 and ≤ 35 kg/m^2 (for SAD and MAD).

3. Generally healthy (as assessed by the investigator) but with low bone mass (for MAD only ).

4. Nonsmokers, or light smokers, defined as ≤ 10 cigarettes/week (for SAD and MAD).

5. 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).

Exclusion Criteria:

1. A bone fracture within 6 months (for SAD only).

2. Previous exposure to AGA2118 (for MAD only).

3. Any condition that would affect bone metabolism or has a history of low energy fractures as documented in medical history (for MAD only).

4. Administration of the any medications that known to affect bone metabolism within 6 months of Day 1 unless otherwise specified (for SAD and MAD).

5. Human immunodeficiency virus (HIV) infection (for SAD and MAD).

6. 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).

7. Evidence of any of the following (for SAD and MAD):

1. 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

2. current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range

3. known intolerance to calcium supplements

4. malignancy within the last 5 years, etc.