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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Hanna Kwak
- Telefonnummer: 857-475-7080
- E-mail: hanna@antliabio.com
Studiesteder
-
-
-
Auckland, New Zealand
- Clinical Trial Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part A: Single Ascending Dose (SAD): AB-110
Participants will be administered a single dose of AB-110 |
AB-110 will be administered by subcutaneous (SC) injection |
|
Placebo komparator: Part A: SAD: AB-110 Matching Placebo
Participants will be administered a single dose of AB-110 matching placebo |
Placebo doses will be administered SC |
|
Eksperimentel: Part B: Multiple Ascending Dose (MAD): AB-110
Participants will be administered multiple doses of AB-110 |
AB-110 will be administered by subcutaneous (SC) injection |
|
Placebo komparator: Part B: MAD: AB-110 Matching Placebo
Participants will be administered multiple doses of AB-110 matching placebo |
Placebo doses will be administered SC |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Adverse Events and Serious Adverse Events, overall, by severity and relationship to AB-110/placebo
Tidsramme: 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 |
Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
|
Incidence of injection site reactions
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Plasma AB-110 concentration
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
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)
Tidsramme: Part A: From baseline up to Day 7; Part B: From baseline up to Day 25
|
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)
Tidsramme: Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
Part A: From baseline up to Day 21; Part B: From baseline up to Day 36
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AB110-101
Plan for individuelle deltagerdata (IPD)
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