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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: Donidalorsen

Study type

Interventional

Funder types

Industry

Identifiers

NCT03263507

ISIS 721744-CS1

Details and patient eligibility

About

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

Enrollment

32 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 <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