Healthy ParticipantsPhase 1ATLASNCT07361354
An Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)
A Phase 1 study testing AGA2118 in people with Healthy Participants and Pharmacokinetic Study, run by Angitia Incorporated Limited at 1 site in United States.
Trial summary
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Pharmacokinetic Study
- What is being tested?
- AGA2118
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 5 Sep 2026
- 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 males or females, aged 18 to 65 years
- 25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
- Meet the criteria for Japanese, Chinese, or Caucasian ethnicity
Who cannot join
- Participating or have participated in another clinical trial within the past 6 months
- Any bone fracture within the past 6 months
- History of myocardial infarction or stroke within the past 12 months
- Malignancy within the past 5 years
- Current hyper- or hypocalcemia
- Pregnant or breastfeeding women, or women planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
Read the detailed description
This Phase 1 ethnobriding study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days.
- Conditions
- Healthy Participants, Pharmacokinetic Study
- Being tested
- AGA2118
- Keywords
- Ethnobridging, Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGA2118Drug
Participants will receive AGA2118 administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118. Receives: Drug: AGA2118 |
| Cohort 2 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118. Receives: Drug: AGA2118 |
| Cohort 3 (Japanese) | Experimental | One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118. Receives: Drug: AGA2118 |
| Cohort 4 (Caucasian) | Experimental | Healthy Caucasian participants will receive a single administration of high dose AGA2118. Receives: Drug: AGA2118 |
| Cohort 5 (Chinese) | Experimental | Healthy Chinese participants will receive a single administration of high dose AGA2118. Receives: Drug: AGA2118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Cmax of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Time to maximum concentration (Tmax)
Tmax of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Area under the concentration-time curve (AUC)
AUC of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Half-life (t1/2)
t1/2 of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Clearance (CL)
CL of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Volume of distribution (Vd)
Vd of AGA2118 after dosing
Measured: Day 1 to up to the end of study (85 days post-dose)
Secondary outcomes (1)
Treatment-emergent adverse events (TEAEs)
Occurrence of TEAEs
Measured: Baseline to the end of study (85 days post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start5 Jan 2026
- Primary completion5 Sep 2026
- Study completion5 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angitia Incorporated Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361354
- Sponsor's protocol ID
- ACT24-006
- Acronym
- ATLAS
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of AGA2118 in Healthy Japanese, Chinese, and Caucasian Participants
- ClinicalTrials.gov ID
- NCT07361354
- Acronym / sponsor ID
- ATLAS / ACT24-006
- Conditions
- Healthy Participants, Pharmacokinetic Study
- Keywords
- Ethnobridging, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Angitia Incorporated LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 5 Sep 2026 (actual)
- Study completion
- 5 Sep 2026 (actual)
- First posted
- 23 Jan 2026 (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.
This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants
Detailed description
This Phase 1 ethnobriding study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Japanese) | Experimental | Drug: AGA2118One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118. |
| Cohort 2 (Japanese) | Experimental | Drug: AGA2118One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118. |
| Cohort 3 (Japanese) | Experimental | Drug: AGA2118One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118. |
| Cohort 4 (Caucasian) | Experimental | Drug: AGA2118Healthy Caucasian participants will receive a single administration of high dose AGA2118. |
| Cohort 5 (Chinese) | Experimental | Drug: AGA2118Healthy Chinese participants will receive a single administration of high dose AGA2118. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females, aged 18 to 65 years
- 25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
- Meet the criteria for Japanese, Chinese, or Caucasian ethnicity
Key exclusion criteria (6 listed)
- Participating or have participated in another clinical trial within the past 6 months
- Any bone fracture within the past 6 months
- History of myocardial infarction or stroke within the past 12 months
- Malignancy within the past 5 years
- Current hyper- or hypocalcemia
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 |
|---|---|---|
| AGA2118Participants will receive AGA2118 administered by subcutaneous injection | Drug | Cohort 1 (Japanese), Cohort 2 (Japanese), Cohort 3 (Japanese), Cohort 4 (Caucasian), Cohort 5 (Chinese) |
Primary outcome
Maximum concentration (Cmax)
Time frame: Day 1 to up to the end of study (85 days post-dose)
Cmax of AGA2118 after dosing
Time to maximum concentration (Tmax)
Time frame: Day 1 to up to the end of study (85 days post-dose)
Tmax of AGA2118 after dosing
Area under the concentration-time curve (AUC)
Time frame: Day 1 to up to the end of study (85 days post-dose)
AUC of AGA2118 after dosing
Half-life (t1/2)
Time frame: Day 1 to up to the end of study (85 days post-dose)
t1/2 of AGA2118 after dosing
Clearance (CL)
Time frame: Day 1 to up to the end of study (85 days post-dose)
CL of AGA2118 after dosing
Volume of distribution (Vd)
Time frame: Day 1 to up to the end of study (85 days post-dose)
Vd of AGA2118 after dosing
1 secondary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Baseline to the end of study (85 days post-dose)
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 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AGA2118 in people with Healthy Participants and Pharmacokinetic Study, 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 3 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 Sep 2026. 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. 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?
Maximum concentration (Cmax) (time frame: Day 1 to up to the end of study (85 days post-dose)). The study lists 6 primary outcomes in all. 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 Sep 2026.