Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Healthy Volunteers

Ionis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Thalassemia

Treatments

Drug: IONIS TMPRSS6-Lrx

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03165864

ISIS 702843-CS1

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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