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

A Randomized, Subject and Investigator-blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of KAE609 Administered Intravenously in Healthy Subjects

ClinicalTrials.gov Identifier: NCT04321252

Novartis Reference Number: CKAE609X2111

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Malaria
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
58 participants
Start date 
Jul 22, 2020
Completion date 
Nov 10, 2020
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
KAE609
iv administration
Drug
Placebo
matching placeo for iv administration

Eligibility 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.

Study Locations

Belgium
Novartis Investigative Site
Recruiting
Antwerpen, B-2060
-
Belgium

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]