Hypertension (HTN)Phase 1NCT07916961
Study of AB-110 in Healthy and Hypertensive Participants
A Phase 1 study testing Active drug in people with Hypertension (HTN) and Healthy Adult Participants, run by Antlia Bioscience, Inc at 1 site in New Zealand.
Trial summary
This Phase 1, randomized, double-blind study is designed to evaluate safety, tolerability, PK, and PD effects of AB-110. This study will be conducted in 2 parts: a single ascending dose (SAD; Part A) in healthy participants with an optional cohort of BMI > 30 kg/m2 and ≤ 35 kg/m2 and multiple ascending dose (MAD; Part… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension (HTN), Healthy Adult Participants
- What is being tested?
- Active drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2026to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Part A 18 - 50 years of age; Part B 18 -65 years of age.
- Part A SBP ≥130 and below 140mmHg and healthy; Part B >140 and ≤165 mmHg
- Part A Body Mass Index in the range of 18 - 30 kg/m2, and minimal weight of 50 kg; Part B 18 - 32 kg/m2, and minimal weight of 50 kg
- Has a normal 12-lead electrocardiogram (ECG)
- Is a nonsmoker
Who cannot join
- Has secondary hypertension
- Has orthostatic hypotension
- Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2
- Has recently received an investigational agent
- Has history of any cardiovascular event
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-110 in Healthy and Hypertensive Participants
This Phase 1, randomized, double-blind study is designed to evaluate safety, tolerability, PK, and PD effects of AB-110. This study will be conducted in 2 parts: a single ascending dose (SAD; Part A) in healthy participants with an optional cohort of BMI > 30 kg/m2 and ≤ 35 kg/m2 and multiple ascending dose (MAD; Part B) in participants with hypertension who are otherwise healthy. Sentinel dosing will be applied in the Part A study at each new dose level to ensure participant's safety.
The study will provide initial insight into the safety and tolerability of AB-110. In addition to safety, the study is designed to enable insights on secondary and exploratory research questions, including Blood Pressure (BP) reduction and exploratory biomarkers.
- Conditions
- Hypertension (HTN), Healthy Adult Participants
- Being tested
- Active drug, AB-110 Matching Placebo
- Keywords
- hypertension, HTN, healthy, Phase 1, SAD, MAD
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active drugDrug
AB-110 will be administered by subcutaneous (SC) injection
AB-110 Matching PlaceboDrug
Placebo doses will be administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD): AB-110 | Experimental | Participants will be administered a single dose of AB-110 Receives: Drug: Active drug |
| Part A: SAD: AB-110 Matching Placebo | Placebo comparator | Participants will be administered a single dose of AB-110 matching placebo Receives: Drug: AB-110 Matching Placebo |
| Part B: Multiple Ascending Dose (MAD): AB-110 | Experimental | Participants will be administered multiple doses of AB-110 Receives: Drug: Active drug |
| Part B: MAD: AB-110 Matching Placebo | Placebo comparator | Participants will be administered multiple doses of AB-110 matching placebo Receives: Drug: AB-110 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events and Serious Adverse Events, overall, by severity and relationship to AB-110/placebo
Adverse events may include abnormal vital signs, safety laboratory tests and ECG parameters that are considered clinically significant
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Incidence of injection site reactions
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Secondary outcomes (8)
Plasma AB-110 concentration
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Maximum Observed Plasma Concentration (Cmax) of AB-110 in healthy and hypertensive participants
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Area Under the Concentration-time Curve (AUC) of AB-110 in healthy and hypertensive participants
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Half-life (T1/2) of AB-110 in healthy and hypertensive participants
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Apparent clearance (CL/F) of AB-110 in healthy and hypertensive participants
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Apparent volume of distribution (Vz/F) of AB-110 in healthy and hypertensive participants
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) assessed by 24-hour Automated Blood Pressure Machine (ABPM)
Measured: Part A: From baseline up to Day 7; Part B: From baseline up to Day 25
Change from baseline in SBP and DBP assessed by Automated Office Blood Pressure (AOBP)
Measured: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antlia Bioscience, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916961
- Sponsor's protocol ID
- AB110-101
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-110 in Healthy and Hypertensive Participants
- ClinicalTrials.gov ID
- NCT07916961
- Acronym / sponsor ID
- AB110-101
- Conditions
- Hypertension (HTN), Healthy Adult Participants
- Keywords
- hypertension, HTN, healthy, Phase 1, SAD, MAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Antlia Bioscience, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Nov 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 Phase 1, randomized, double-blind study is designed to evaluate safety, tolerability, PK, and PD effects of AB-110. This study will be conducted in 2 parts: a single ascending dose (SAD; Part A) in healthy participants with an optional cohort of BMI > 30 kg/m2 and ≤ 35 kg/m2 and multiple ascending dose (MAD; Part B) in participants with hypertension who are otherwise healthy. Sentinel dosing will be applied in the Part A study at each new dose level to ensure participant's safety.
The study will provide initial insight into the safety and tolerability of AB-110. In addition to safety, the study is designed to enable insights on secondary and exploratory research questions, including Blood Pressure (BP) reduction and exploratory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD): AB-110 | Experimental | Drug: Active drugParticipants will be administered a single dose of AB-110 |
| Part A: SAD: AB-110 Matching Placebo | Placebo comparator | Drug: AB-110 Matching PlaceboParticipants will be administered a single dose of AB-110 matching placebo |
| Part B: Multiple Ascending Dose (MAD): AB-110 | Experimental | Drug: Active drugParticipants will be administered multiple doses of AB-110 |
| Part B: MAD: AB-110 Matching Placebo | Placebo comparator | Drug: AB-110 Matching PlaceboParticipants will be administered multiple doses of AB-110 matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Part A 18 - 50 years of age; Part B 18 -65 years of age.
- Part A SBP ≥130 and below 140mmHg and healthy; Part B >140 and ≤165 mmHg
- Part A Body Mass Index in the range of 18 - 30 kg/m2, and minimal weight of 50 kg; Part B 18 - 32 kg/m2, and minimal weight of 50 kg
- Has a normal 12-lead electrocardiogram (ECG)
- Is a nonsmoker
Key exclusion criteria (6 listed)
- Has secondary hypertension
- Has orthostatic hypotension
- Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2
- Has recently received an investigational agent
- Has history of any cardiovascular event
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 |
|---|---|---|
| Active drugAB-110 will be administered by subcutaneous (SC) injection | Drug | Part A: Single Ascending Dose (SAD): AB-110, Part B: Multiple Ascending Dose (MAD): AB-110 |
| AB-110 Matching PlaceboPlacebo doses will be administered SC | Drug | Part A: SAD: AB-110 Matching Placebo, Part B: MAD: AB-110 Matching Placebo |
Primary outcome
Incidence of Adverse Events and Serious Adverse Events, overall, by severity and relationship to AB-110/placebo
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Adverse events may include abnormal vital signs, safety laboratory tests and ECG parameters that are considered clinically significant
Incidence of injection site reactions
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
8 secondary outcomes
Plasma AB-110 concentration
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Maximum Observed Plasma Concentration (Cmax) of AB-110 in healthy and hypertensive participants
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Area Under the Concentration-time Curve (AUC) of AB-110 in healthy and hypertensive participants
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Half-life (T1/2) of AB-110 in healthy and hypertensive participants
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Apparent clearance (CL/F) of AB-110 in healthy and hypertensive participants
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Apparent volume of distribution (Vz/F) of AB-110 in healthy and hypertensive participants
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) assessed by 24-hour Automated Blood Pressure Machine (ABPM)
Time frame: Part A: From baseline up to Day 7; Part B: From baseline up to Day 25
Change from baseline in SBP and DBP assessed by Automated Office Blood Pressure (AOBP)
Time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
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 Active drug in people with Hypertension (HTN) and Healthy Adult Participants, run by Antlia Bioscience, Inc at 1 site in New Zealand.
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 5 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: opening soon, as of the sponsor's last update on 4 Nov 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 New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Kwak (857-475-7080, hanna@antliabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events and Serious Adverse Events, overall, by severity and relationship to AB-110/placebo (time frame: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36). The study lists 2 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 4 Nov 2026.