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

• Status: Completed
• Trial end date: 2018-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Criteria

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