Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects

• Status: Completed
• Trial end date: 2020-11-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to assess the safety and blood levels of study drug KAE609 given in the vein.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborators: This trial is supported in part by Wellcome Trust via Grant # Grant Number 217692/Z/19/Z; Wellcome Trust

Criteria

Key Inclusion Criteria:

• Healthy male and female subjects 18 to 55 years of age includsive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.

• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2.

Key Exclusion Criteria:

• Use of other investigational drugs within 5 half-lives of Screening, or within 30 days of dosing, whichever is longer; or longer if required by local regulations.

• Significant illness which has not resolved within two (2) weeks prior to initial dosing.

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

• Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for at least 2 weeks after last dose of investigational drug.