Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to 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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-28

Study Completion Date

2018-10-09

Brief Summary

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The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to 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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Donidalorsen

Ascending single and multiple doses of Donidalorsen administered subcutaneously

Group Type EXPERIMENTAL

Donidalorsen

Intervention Type DRUG

Donidalorsen administered subcutaneously

Placebo (sterile saline 0.9%)

Calculated volume to match active comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline .9%

Interventions

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Placebo

Saline .9%

Intervention Type DRUG

Donidalorsen

Donidalorsen administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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ISIS 721744 IONIS-PKK-LRx

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 18-65 inclusive 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/m2

Exclusion Criteria

* Clinically-significant abnormalities in medical history including acute coronary syndrome, major surgery within 3 months of Screening, planned surgery that would occur during the study or physical examination or other screening results such as ECGs at Screening
* Clinically significant hematologic, chemistry, and urine abnormalities
* Treatment with another Study Drug, biological agent, or device within 4 weeks of Screening
* History of bleeding diathesis or coagulopathy
* Smoking \>10 cigarettes per day
* Considered unsuitable for inclusion by the Principal Investigator
* Current use of concomitant medications (including herbal or OTC medications) unless approved by Sponsor Medical Monitor
* Known history or positive test for HIV, hepatitis C or chronic hepatitis B
* Blood donation within 30 days of screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes