Healthy Volunteers
Conditions
Keywords
IONIS PKK-LRx
Brief summary
The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers
Interventions
DRUGPlacebo
Saline .9%
DRUGDonidalorsen
Donidalorsen administered subcutaneously
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events that are related to treatment with Donidalorsen | Up to 176 days | The safety and tolerability of multiple doses of Donidalorsen will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with Donidalorsen. |
| Peak plasma Concentration (Cmax) of Donidalorsen | Up to 176 days | Maximum Donidalorsen plasma concentration, Cmax (ug/mL) will be assessed following SC administration |
| Time to peak plasma Concentration (Tmax) of Donidalorsen | Up to 176 days | Time to peak Donidalorsen plasma concentration, Tmax (hours) will be assessed following SC administration |
| Effects of Donidalorsen on plasma PKK concentration | Up to 176 days | Effects of Donidalorsen on plasma PKK concentration after multiple doses of Donidalorsen compared to baseline |
Countries
Canada
Outcome results
None listed