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

Healthy Volunteers Clinical Trial

Official title:

A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101878
• Other study ID #: ISIS 757456-CS1
• Status: Completed
• Phase: Phase 1
• Start date: April 5, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2018
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 1, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Ionis AGT-LRx
Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously
• Placebo
Saline .9%

Locations

Country	Name	City	State
Canada	Syneos Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx	The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with IONIS AGT-LRx	Up to 127 days
Primary	Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline	The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by reviewing any observed changes in Blood Pressure measurements, physical exam, and laboratory tests from baseline by dose. Results in subjects dosed with IONIS AGT-LRx will be compared with those from subjects dosed with placebo.	Up to 127 days
Secondary	Pharmacokinetics after single and multiple doses of IONIS AGT-LRx	The plasma pharmacokinetics (concentration-time results) of IONIS AGT-LRx will be assessed following single and multiple dose SC administration	Up to 127 days
Secondary	Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels)	Effects of IONIS AGT-LRx on changes in AGT plasma protein compared to baseline.	Up to 127 days