Osteogenesis ImperfectaPhase 1NCT06086613
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
A Phase 1 study testing AGA2115 in people with Osteogenesis Imperfecta, run by Angitia Incorporated Limited at 1 site in United States.
Trial summary
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- AGA2115
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 17 Oct 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women ≥18 to ≤65 years old.
- Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.
Who cannot join
- History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
- Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
- Hyper- or hypocalcemia.
- Known sensitivity to mammalian-derived drug preparations and/or any biologics.
- Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Lake Forest, California, 92630
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AGA2115 in Adult Healthy Volunteers
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- AGA2115, Placebo
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA2115Drug
In Part A, participants will receive AGA2115 as a single dose administered as a subcutaneous (SC) injection (5 cohorts) or as an intravenous (IV) infusion (1 cohort).
In Part B, participants will receive AGA2115 in multiple doses administered as a SC injection.
PlaceboDrug
In Part A, participants will receive single dose of placebo administered as a SC injection (5 cohorts) or IV infusion (1 cohort).
In Part B, participants will receive multiple doses of placebo administered as a SC injection.
| Study group | Role | What they receive |
|---|---|---|
| AGA2115 | Experimental | In Part A, up to 6 single ascending dose cohorts.
In Part B, up to 3 multiple ascending dose cohorts. Receives: Drug: AGA2115 |
| Placebo | Placebo comparator | Participants will receive matching placebo. 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 (TEAEs)
Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs.
Measured: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Secondary outcomes (3)
Maximum observed concentration (Cmax) of AGA2115
Measured: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Time to maximum observed concentration (Tmax) of AGA2115
Measured: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Area under the concentration time curve (AUC) of AGA2115
Measured: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start3 Oct 2023
- Primary completion17 Oct 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angitia Incorporated Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angitia Medical Director, Study director, Angitia Incorporated Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086613
- Sponsor's protocol ID
- ACT22-002
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. 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, Pharmacokinetics, and Pharmacodynamics of AGA2115 in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06086613
- Acronym / sponsor ID
- ACT22-002
- Conditions
- Osteogenesis Imperfecta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Angitia Incorporated LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 17 Oct 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 17 Oct 2023 (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.
To understand if AGA2115 is safe and well tolerated in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGA2115 | Experimental | Drug: AGA2115In Part A, up to 6 single ascending dose cohorts. In Part B, up to 3 multiple ascending dose cohorts. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy men and women ≥18 to ≤65 years old.
- Vitamin D sufficiency (≥20 ng/mL (50 nmol/L) and agree to taking Calcium and Vitamin D supplements during the trial.
Key exclusion criteria (6 listed)
- History of myocardial infarction or stroke (or other cardiovascular associated event deemed significant by investigator) within 12 months prior to Day 1.
- Malignancy within the last 5 years (basal cell carcinoma and squamous cell carcinoma that have been excised with no recurrence within the last 5 years is allowed).
- Hyper- or hypocalcemia.
- Known sensitivity to mammalian-derived drug preparations and/or any biologics.
- Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study.
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 |
|---|---|---|
| AGA2115In Part A, participants will receive AGA2115 as a single dose administered as a subcutaneous (SC) injection (5 cohorts) or as an intravenous (IV) infusion (1 cohort). In Part B, participants will receive AGA2115 in multiple doses administered as a SC injection. | Drug | AGA2115 |
| PlaceboIn Part A, participants will receive single dose of placebo administered as a SC injection (5 cohorts) or IV infusion (1 cohort). In Part B, participants will receive multiple doses of placebo administered as a SC injection. | Drug | Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Clinically significant changes in clinical laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs) will be recorded as TEAEs.
3 secondary outcomes
Maximum observed concentration (Cmax) of AGA2115
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Time to maximum observed concentration (Tmax) of AGA2115
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
Area under the concentration time curve (AUC) of AGA2115
Time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)
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 10 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
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Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
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GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
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Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
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Setrusumab vs Placebo for Osteogenesis Imperfecta
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGA2115 in people with Osteogenesis Imperfecta, run by Angitia Incorporated Limited at 1 site in United States.
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 2 inclusion and 6 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 (TEAEs) (time frame: Day 1 to up to end of study (approximately 85 days in Part A, approximately 169 days in Part B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.