A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 696844 Administered Subcutaneously to Healthy Volunteers

Phase 1

Completed

• Conditions: Age-Related Macular Degeneration; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12616000335493
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Must have given written informed consent and be able to comply with study requirements
2. Healthy males or females aged > 25 years at the time of informed consent.
3. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent* or, if engaged in sexual relations with a female of childbearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent until at least 90 days after the subject’s last dose of Study Drug (ISIS 696844 or placebo)
4. Body weight > 50 kg at the time of informed consent

Exclusion Criteria

1. Clinical significant abnormalities in medical history, lab tests or physical exam
2 Abnormalities in complement.
3. Known history of or positive test for human immunodeficiency (HIV), hepatitis C or hepatitis B
4. Treatment with another Study Drug, biological agent, or device within one-month of screening
5. Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
6. Smoking > 10 cigarettes a day

Study & Design

• Study Type: Interventional
• Study Design: Not specified