Status:
COMPLETED
Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Wellcome Trust
Conditions:
Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE6...
Detailed Description
The study consisted of 2 parts: single-ascending dose (SAD) part and multiple ascending dose (MAD) part. In Part A (Single-ascending dose (SAD) part), it was planned to recruit 6 active, 2 placebo su...
Eligibility Criteria
Inclusion
- Key
- Healthy male and female subjects 18 to 55 years of age inclusive, 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
- 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.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04321252
Start Date
July 22 2020
End Date
November 10 2020
Last Update
December 13 2021
Active Locations (1)
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1
Novartis Investigative Site
Antwerp, Belgium, B-2060