NCT04321252

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	KAE609	* iv bolus administration over approximately 2 min for doses \< 75 mg (Cohorts A1, A2 and B1) * iv infusion over approximately 10 min for doses ≥ 75 mg (Cohorts A3, A4, A5 and B2)
DRUG	Placebo	matching placeo for iv administration

Timeline

• Start date: 2020-07-22
• Primary completion: 2020-11-10
• Completion: 2020-11-10
• First posted: 2020-03-25
• Last updated: 2021-12-13
• Results posted: 2021-12-13

Locations

1 site across 1 country: Belgium