OsteoporosisPhase 1NCT05225857

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

A Phase 1 study testing AGA2118 in people with Osteoporosis, run by Angitia Biopharmaceuticals at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Osteoporosis
What is being tested?: AGA2118
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 2 sitesAustralia
Study dates: 28 Jun 2022to 13 Jan 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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).

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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.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

Q-Pharm Pty Ltd
Brisbane, Queensland, 4006
Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Phase 1, 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

Read the 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
Being tested: AGA2118, Placebo
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AGA2118Drug
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.
PlaceboDrug
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.

Study groups in NCT05225857
Study group	Role	What they receive
AGA2118	Experimental	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. Receives: Drug: AGA2118
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-emergent adverse events (TEAE) in Part 1 (SAD).
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Measured: Up to 85 days
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 1 (SAD).
Serum calcium tested at Day 2, 4, 6, 15, 29, 85.
Measured: Up to 85 days
Number of participants with clinically significant changes in blood pressure in Part 1 (SAD).
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85).
Measured: Up to 85 days
Number of participants with clinically significant changes in heart rate in Part 1 (SAD).
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 85.
Measured: Up to 85 days
Number of participants with clinically significant changes in QTcF in Part 1 (SAD).
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 43, 57, 71, 85.
Measured: Up to 85 days
Number of participants with treatment-emergent adverse events (TEAE) in Part 2 (MAD).
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Measured: Up to 169 days
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 2 (MAD).
Serum calcium tested at Day 2, 8, 15, 29, 36, 57, 64, 85, 169.
Measured: Up to 169 days
Number of participants with clinically significant changes in blood pressure in Part 2 (MAD).
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 4, 6, 8, 15, 22, 29, 36, 43, 57, 58, 60, 62, 64, 71, 78, 85, 99, 113, 127, 141, 155, 169).
Measured: Up to 169 days
Number of participants with clinically significant changes in heart rate in Part 2 (MAD).
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.
Measured: Up to day 169
Number of participants with clinically significant changes in QTcF in Part 2 (MAD).
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.
Measured: Up to day 169

Secondary outcomes (4)

Maximum Concentration (Cmax) of AGA2118
Maximum concentration of AGA2118 after dosing.
Measured: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Time to maximum concentration (Tmax) of AGA2118
Time to maximum concentration of AGA2118 after dosing.
Measured: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Area under the concentration time curve (AUC)
Definite integral of the curve describing the variation of AGA2118 in blood as a function of time.
Measured: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Terminal elimination half-life (t1/2)
Time it takes for maximum concentration to half of maximum concentration of AGA2118.
Measured: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 202213 Jan 2024

First posted7 Feb 2022
Study start28 Jun 2022
Primary completion13 Jan 2024
Study completion13 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05225857
Sponsor's protocol ID: 21-001
Status last verified: Feb 2023
First submitted: 11 Jan 2022
Last updated: 5 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, 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
ClinicalTrials.gov ID: NCT05225857
Acronym / sponsor ID: 21-001
Conditions: Osteoporosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Angitia BiopharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Angitia Australia Pty Ltd
Study start: 28 Jun 2022 (actual)
Primary completion: 13 Jan 2024 (actual)
Study completion: 13 Jan 2024 (actual)
First posted: 7 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
AGA2118	Experimental	Drug: AGA2118In 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.
Placebo	Placebo comparator	Drug: PlaceboIn 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.

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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).

Key exclusion criteria (11 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AGA2118Part 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.	Drug	AGA2118
PlaceboPart 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.	Drug	Placebo

Primary outcome

Number of participants with treatment-emergent adverse events (TEAE) in Part 1 (SAD).
Time frame: Up to 85 days
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 1 (SAD).
Time frame: Up to 85 days
Serum calcium tested at Day 2, 4, 6, 15, 29, 85.
Number of participants with clinically significant changes in blood pressure in Part 1 (SAD).
Time frame: Up to 85 days
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85).
Number of participants with clinically significant changes in heart rate in Part 1 (SAD).
Time frame: Up to 85 days
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 85.
Number of participants with clinically significant changes in QTcF in Part 1 (SAD).
Time frame: Up to 85 days
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 6, 15, 29, 43, 57, 71, 85.
Number of participants with treatment-emergent adverse events (TEAE) in Part 2 (MAD).
Time frame: Up to 169 days
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational product (IP), whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP.
Number of participants with clinically significant changes in total calcium (albumin-adjusted) in Part 2 (MAD).
Time frame: Up to 169 days
Serum calcium tested at Day 2, 8, 15, 29, 36, 57, 64, 85, 169.
Number of participants with clinically significant changes in blood pressure in Part 2 (MAD).
Time frame: Up to 169 days
Systolic and diastolic blood pressure measured (mmHg) at all clinic visits (Day 1, 2, 4, 6, 8, 15, 22, 29, 36, 43, 57, 58, 60, 62, 64, 71, 78, 85, 99, 113, 127, 141, 155, 169).
Number of participants with clinically significant changes in heart rate in Part 2 (MAD).
Time frame: Up to day 169
Heart rate measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.
Number of participants with clinically significant changes in QTcF in Part 2 (MAD).
Time frame: Up to day 169
QTcF (QT interval corrected for heart rate using Fridericia's formula) measured by electrocardiogram (ECG) on Day 1, 2, 4, 15, 29, 36, 57, 64, 85, 169.

4 secondary outcomes

Maximum Concentration (Cmax) of AGA2118
Time frame: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Time to maximum concentration (Tmax) of AGA2118
Time frame: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Area under the concentration time curve (AUC)
Time frame: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169
Terminal elimination half-life (t1/2)
Time frame: Part 1 (SAD): up to day 85; Part 2 (MAD) up to day 169

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
Individual participant dataSharing planned: No

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Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angitia Medical Director study director

Angitia Incorporated Limited

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AGA2118 in people with Osteoporosis, run by Angitia Biopharmaceuticals at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-emergent adverse events (TEAE) in Part 1 (SAD). (time frame: Up to 85 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05225857.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.