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

Malaria Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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 KAE609 given in the vein.

Clinical Trial 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 subjects in each cohort:

• Cohort A1: 10.5 mg/placebo

• Cohort A2: 30 mg/placebo

• Cohort A3: 75 mg/placebo

• Cohort A4: 120 mg/placebo

• Cohort A5: 210 mg/placebo

In Part B (Multiple-ascending dose (MAD) part), Subjects were assigned to one of the following treatment arms in a ratio of 2:1 (6 active, 3 placebo):

• Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days

• Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days

Eligible subjects were randomized to receive a single or q24h x 5 doses of either KAE609 or placebo. Safety, tolerability and pharmacokinetics were assessed over the period of 8 days for single dose and 12 days for multiple dose up to end of study visit for each subject. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT04321252
• Study type: Interventional
• Source: Novartis
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2020
• Completion date: November 10, 2020