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

Novartis

Status and phase: Completed; Phase 1

Conditions: Malaria

Treatments: Drug: Placebo; Drug: KAE609

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04321252

CKAE609X2111

2019-000405-71 (EudraCT Number)

217692/Z/19/Z (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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57 participants in 7 patient groups

Cohort A1: 10.5 mg/placebo

Experimental group

Description:

Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

Cohort A2: 30 mg/placebo

Experimental group

Description:

Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

Cohort A3: 75 mg/placebo

Experimental group

Description:

Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

Cohort A4: 120 mg/placebo

Experimental group

Description:

Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

Cohort A5: 210 mg/placebo

Experimental group

Description:

Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

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

Experimental group

Description:

Multiple iv bolus doses of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609

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

Experimental group

Description:

Multiple iv infusion doses of KAE609 or placebo administered at the clinical site by the study personnel.

Treatment:

Drug: Placebo

Drug: KAE609