Study of AB-110 in Healthy and Hypertensive Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants; Hypertension (HTN)
• Intervention / Treatment: Drug: Active drug; Drug: AB-110 Matching Placebo

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hanna Kwak; Phone Number: 857-475-7080; Email: hanna@antliabio.com

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Single Ascending Dose (SAD): AB-110; Participants will be administered a single dose of AB-110	Drug: Active drug; AB-110 will be administered by subcutaneous (SC) injection
Placebo Comparator: Part A: SAD: AB-110 Matching Placebo; Participants will be administered a single dose of AB-110 matching placebo	Drug: AB-110 Matching Placebo; Placebo doses will be administered SC
Experimental: Part B: Multiple Ascending Dose (MAD): AB-110; Participants will be administered multiple doses of AB-110	Drug: Active drug; AB-110 will be administered by subcutaneous (SC) injection
Placebo Comparator: Part B: MAD: AB-110 Matching Placebo; Participants will be administered multiple doses of AB-110 matching placebo	Drug: AB-110 Matching Placebo; Placebo doses will be administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
Incidence of injection site reactions		Part A: From baseline up to Day 21; Part B: From baseline up to Day 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma AB-110 concentration	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	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	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	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	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	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)	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)	Part A: From baseline up to Day 21; Part B: From baseline up to Day 36

Collaborators and Investigators

• Sponsor: Antlia Bioscience, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: October 22, 2026
• First Submitted That Met QC Criteria: October 28, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 28, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; Phase 1; healthy; SAD; MAD; HTN
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Pharmaceutical Preparations; Bulk Drugs
• Other Study ID Numbers: AB110-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No