Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-05

Study Completion Date

2018-08-01

Brief Summary

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The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ionis AGT-LRx

Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously.

Group Type EXPERIMENTAL

Ionis AGT-LRx

Intervention Type DRUG

Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously

Placebo

Saline .9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline .9%

Interventions

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Ionis AGT-LRx

Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously

Intervention Type DRUG

Placebo

Saline .9%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-60 inclusive and weighing ≥ 50 kg at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI ≤ 35 kg/m
* Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects

Exclusion Criteria

* Treatment with another Study Drug, biological agent, or device within one-month of Screening
* Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
* Use of nicotine-containing products or illicit drugs
* Considered unsuitable for inclusion by the Principal Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes