Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03263507
Start Date
August 28 2017
End Date
October 9 2018
Last Update
August 4 2022
Active Locations (1)
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1
Ionis Investigative Site
Toronto, Ontario, Canada, M9L 3A2