NCT04321252

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 KAE609 given in the vein.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 22, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 13, 2021

Completed
Last Updated

December 13, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

March 23, 2020

Results QC Date

October 27, 2021

Last Update Submit

October 27, 2021

Conditions

Malaria

Keywords

safetytolerabilitypharmacokineticshealthy volunteersphase 1malariaintravenousivKAE609Placebo

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths

    The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.

    From study treatment start date till 30 days safety follow-up, assessed for up to 4 months

Secondary Outcomes (15)

  • Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)

    Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

  • Part A - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)

    Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

  • Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

    Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

  • Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)

    Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

  • Part A - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)

    Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

  • +10 more secondary outcomes

Study Arms (7)

Cohort A1: 10.5 mg/placebo

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

Cohort A2: 30 mg/placebo

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

Cohort A3: 75 mg/placebo

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

Cohort A4: 120 mg/placebo

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

Cohort A5: 210 mg/placebo

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

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

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

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

EXPERIMENTAL

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

Drug: KAE609Drug: Placebo

Interventions

KAE609DRUG

* 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)

Cohort A1: 10.5 mg/placeboCohort A2: 30 mg/placeboCohort A3: 75 mg/placeboCohort A4: 120 mg/placeboCohort A5: 210 mg/placeboCohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 daysCohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days
PlaceboDRUG

matching placeo for iv administration

Cohort A1: 10.5 mg/placeboCohort A2: 30 mg/placeboCohort A3: 75 mg/placeboCohort A4: 120 mg/placeboCohort A5: 210 mg/placeboCohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 daysCohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Antwerp, B-2060, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 39058022DERIVED

MeSH Terms

Conditions

Malaria

Interventions

NITD 609

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

July 22, 2020

Primary Completion

November 10, 2020

Study Completion

November 10, 2020

Last Updated

December 13, 2021

Results First Posted

December 13, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)