Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2018-09-25

Brief Summary

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The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers

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Detailed Description

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Conditions

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Thalassemia

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 TMPRSS6-Lrx

Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously

Group Type EXPERIMENTAL

IONIS TMPRSS6-Lrx

Intervention Type DRUG

Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously

Placebo

Saline .9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline .9%

Interventions

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IONIS TMPRSS6-Lrx

Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously

Intervention Type DRUG

Placebo

Saline .9%

Intervention Type OTHER

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 \< 32 kg/m2

Exclusion Criteria

* Clinically significant abnormalities in medical history or physical examination
* Clinically significant lab abnormalities that would render a subject unsuitable for inclusion
* Known history or positive test for HIV, HCV, or HBV
* Treatment with another Study Drug, biological agent, or device within one-month of Screening or 5 half-lives of investigational agent, whichever is longer
* Smoking \> 10 cigarettes per day
* Regular excessive use of alcohol within 6 months of screening
* Current use of concomitant medications other than occasional acetaminophen (paracetamol) or ibuprofen unless approved by Sponsor Medical Monitor
* Considered unsuitable for inclusion by the Investigator or Sponsor

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes