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

NCT ID: NCT04321252

Last Updated: 2021-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-22

Study Completion Date

2020-11-10

Brief Summary

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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

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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

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Malaria

Keywords

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safety tolerability pharmacokinetics healthy volunteers phase 1 malaria intravenous iv KAE609 Placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort A1: 10.5 mg/placebo

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

Cohort A2: 30 mg/placebo

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

Cohort A3: 75 mg/placebo

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

Cohort A4: 120 mg/placebo

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

Cohort A5: 210 mg/placebo

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

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

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

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

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

Group Type EXPERIMENTAL

KAE609

Intervention Type DRUG

* 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)

Placebo

Intervention Type DRUG

matching placeo for iv administration

Interventions

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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)

Intervention Type DRUG

Placebo

matching placeo for iv administration

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Antwerp, , Belgium

Site Status

Countries

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Belgium

References

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Venishetty VK, Lecot J, Nguyen A, Zhang J, Prince WT. First-in-human, randomized, double-blind, placebo-controlled, single and multiple ascending doses clinical study to assess the safety, tolerability, and pharmacokinetics of cipargamin administered intravenously in healthy adults. Antimicrob Agents Chemother. 2024 Sep 4;68(9):e0128723. doi: 10.1128/aac.01287-23. Epub 2024 Jul 26.

Reference Type DERIVED
PMID: 39058022 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-000405-71

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

217692/Z/19/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CKAE609X2111

Identifier Type: -

Identifier Source: org_study_id