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

NCT ID: NCT05225857

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2024-01-13

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 the safety and tolerability of AGA2118 after multiple subcutaneous administrations in men and postmenopausal women.

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 Pharmacodynamics of AGA2118 in Men and Postmenopausal Women.

The study consists of the single ascending dose (SAD) part and the multiple ascending dose (MAD) part. In the SAD part, up to 56 healthy men and postmenopausal women will be sequentially enrolled to receive a single subcutaneous (SC) dose of AGA2118 or a single intravenous (IV) dose of AGA2118 or placebo. In the MAD part, up to 32 healthy men and postmenopausal women will be sequentially enrolled in various dose cohorts to receive multiple SC doses every 4 weeks of AGA2118 or placebo.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AGA2118

In SAD part, various single doses of AGA2118 will be administered to the participants via either SC injection or IV infusion. The starting dose was 0.3 mg/kg, with sequential escalation up to 15 mg/kg.

In MAD part, various multiple doses of AGA2118 will be administered every four weeks (Q4W) to the participants via SC injection for 12 weeks. The starting dose was 1 mg/kg, with sequential escalation up to 12 mg/kg.

Group Type: EXPERIMENTAL

AGA2118

Intervention Type: DRUG

Part 1 - SAD study: SAD participants in various cohorts will receive various single dose of AGA2118 via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive various multiple doses of AGA2118 Q4W via SC.

Placebo

In SAD part, a single dose of placebo comparator will be used for each cohort of either SC or IV administration.

In MAD part, multiple doses of placebo comparator will be used for each cohort of SC administration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Part 1 - SAD study: SAD participants in various cohorts will receive a single dose of placebo via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive multiple doses of placebo via SC.

Interventions

AGA2118

Part 1 - SAD study: SAD participants in various cohorts will receive various single dose of AGA2118 via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive various multiple doses of AGA2118 Q4W via SC.

Intervention Type: DRUG

Placebo

Part 1 - SAD study: SAD participants in various cohorts will receive a single dose of placebo via either SC or IV.

Part 2 - MAD study: MAD participants in various cohorts will receive multiple doses of placebo via SC.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy men ≥ 30 and ≤ 65 years of age or postmenopausal women ≥ 45 and ≤ 65 years of age for SAD and MAD;

2. BMI ≥ 18.5 and ≤ 32 kg/m^2 (for SAD and MAD).

3. Generally healthy (as assessed by the investigator).

4. Nonsmokers, or light smokers, defined as ≤ 3 cigarettes/day (or equivalent) (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).

6. 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 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Angitia Australia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Angitia Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angitia Medical Director

Role: STUDY_DIRECTOR

Angitia Incorporated Limited

Locations

Q-Pharm Pty Ltd

Brisbane, Queensland, Australia

Nucleus Network Pty Ltd.

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

21-001

Identifier Type: -

Identifier Source: org_study_id