MalariaPhase 1NCT04321252

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

A Phase 1 study testing KAE609 in people with Malaria, run by Novartis Pharmaceuticals at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Malaria
What is being tested?: KAE609
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteBelgium
Study dates: 22 Jul 2020to 10 Nov 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Belgium1 site

Novartis Investigative Site
Antwerp, B-2060

Other trials in Belgium

About this study

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

Read the 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
Being tested: KAE609, Placebo
Keywords: safety, tolerability, pharmacokinetics, healthy volunteers, phase 1, malaria, intravenous, iv, KAE609, Placebo
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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)
PlaceboDrug
matching placeo for iv administration

Study groups in NCT04321252
Study group	Role	What they receive
Cohort A1: 10.5 mg/placebo	Experimental	Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel. Receives: Drug: KAE609; Drug: Placebo
Cohort A2: 30 mg/placebo	Experimental	Single iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel. Receives: Drug: KAE609; Drug: Placebo
Cohort A3: 75 mg/placebo	Experimental	Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. Receives: Drug: KAE609; Drug: Placebo
Cohort A4: 120 mg/placebo	Experimental	Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. Receives: Drug: KAE609; Drug: Placebo
Cohort A5: 210 mg/placebo	Experimental	Single iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel. Receives: Drug: KAE609; Drug: 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. Receives: Drug: KAE609; Drug: 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. Receives: Drug: KAE609; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: 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)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics.
Measured: 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)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: 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)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUCinf was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: 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)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was calculated from plasma concentration-time data using non-compartmental methods based on the actual time of sample collection and summarized using descriptive statistics.
Measured: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUClast was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC0-24hrs was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Vz was calculated from plasma concentration-time data using non-compartmental methods and summarized using descriptive statistics.
Measured: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202010 Nov 2020

First posted25 Mar 2020
Study start22 Jul 2020
Primary completion10 Nov 2020
Study completion10 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04321252
Sponsor's protocol ID: CKAE609X2111
Other IDs: 2019-000405-71, 217692/Z/19/Z, 2019
Status last verified: Oct 2021
First submitted: 23 Mar 2020
Last updated: 13 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39058022

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malaria trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04321252
Acronym / sponsor ID: CKAE609X2111
Conditions: Malaria
Keywords: safety, tolerability, pharmacokinetics, healthy volunteers, phase 1, malaria, intravenous, iv
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Wellcome Trust
Study start: 22 Jul 2020 (actual)
Primary completion: 10 Nov 2020 (actual)
Study completion: 10 Nov 2020 (actual)
First posted: 25 Mar 2020 (actual)
Results: Posted 13 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Cohort A1: 10.5 mg/placebo	Experimental	Drug: KAE609, Drug: PlaceboSingle iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort A2: 30 mg/placebo	Experimental	Drug: KAE609, Drug: PlaceboSingle iv bolus dose of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort A3: 75 mg/placebo	Experimental	Drug: KAE609, Drug: PlaceboSingle iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort A4: 120 mg/placebo	Experimental	Drug: KAE609, Drug: PlaceboSingle iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort A5: 210 mg/placebo	Experimental	Drug: KAE609, Drug: PlaceboSingle iv infusion dose of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days	Experimental	Drug: KAE609, Drug: PlaceboMultiple iv bolus doses of KAE609 or placebo administered at the clinical site by the study personnel.
Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days	Experimental	Drug: KAE609, Drug: PlaceboMultiple iv infusion doses of KAE609 or placebo administered at the clinical site by the study personnel.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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 (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	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, Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days, Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days
Placebomatching placeo for iv administration	Drug	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, Cohort B1: 60 mg/placebo, every 24 hours (q24h) × 5 days, Cohort B2: 120 mg/placebo, every 24 hours (q24h) × 5 days

Primary outcome

Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths
Time frame: From study treatment start date till 30 days safety follow-up, assessed for up to 4 months
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.

15 secondary outcomes

Part A - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Time frame: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
Time frame: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part A - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
Time frame: Day 1 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Time to Reach the Maximum Concentration After Drug Administration (Tmax)
Time frame: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24hrs)
Time frame: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Terminal Elimination Half-life (T1/2)
Time frame: Days 1 and 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Clearance From Plasma (CL) Following Drug Administration
Time frame: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)
Part B - Pharmacokinetic of KAE609: Apparent Volume of Distribution During Terminal Phase (Vz)
Time frame: Day 5 (-1 hr, 2 min, 10 min, 30 min, 1 hr, 3 hr, 6 hr, 12 hr)

Results and safety

Results posted to the registry on 13 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)	6	6
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)	6	6
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)	6	6
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)	6	6
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)	6	6
Part A (Single-ascending Dose (SAD): Pooled Placebo	9	8
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)	6	6
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)	6	6
Part B (Multiple-ascending Dose (MAD): Pooled Placebo	6	6

Primary outcome: Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths

Time frame: From study treatment start date till 30 days safety follow-up, assessed for up to 4 months. Count of participants. Unit: Participants

Measure	Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg) n = 6	Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg) n = 6	Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg) n = 6	Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg) n = 6	Part A (Single-ascending Dose (SAD): Pooled KAE609 n = 30	Part A (Single-ascending Dose (SAD): Pooled Placebo n = 9	Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg) n = 6	Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg) n = 6	Part B (Multiple-ascending Dose (MAD): Pooled KAE609 n = 12	Part B (Multiple-ascending Dose (MAD): Pooled Placebo n = 6
Adverse Events (AEs)	1	1	2	6	10	5	4	6	10	4
Serious Adverse Events (SAEs)	0	0	1	0	1	0	0	0	0	0
Deaths	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: On-treatment Adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, assessed for up to 4 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A (Single-ascending Dose (SAD): Cohort A1 (KAE609 10.5 mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Part A (Single-ascending Dose (SAD): Cohort A2 (KAE609 30 mg)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A (Single-ascending Dose (SAD): Cohort A3 (KAE609 75 mg)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part A (Single-ascending Dose (SAD): Cohort A4 (KAE609 120 mg)	1 of 6 (16.7%)	2 of 6 (33.3%)	0 of 6
Part A (Single-ascending Dose (SAD): Cohort A5 (KAE609 210 mg)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part A (Single-ascending Dose (SAD): Pooled KAE609	1 of 30 (3.3%)	10 of 30 (33.3%)	0 of 30
Part A (Single-ascending Dose (SAD): Pooled Placebo	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Part B (Multiple-ascending Dose (MAD): Cohort B1 (KAE609 60 mg)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part B (Multiple-ascending Dose (MAD): Cohort B2 (KAE609 120 mg)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part B (Multiple-ascending Dose (MAD): Pooled KAE609	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Part B (Multiple-ascending Dose (MAD): Pooled Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39058022Venishetty 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.
Individual participant dataSharing planned: No

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RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KAE609 in people with Malaria, run by Novartis Pharmaceuticals at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Deaths (time frame: From study treatment start date till 30 days safety follow-up, assessed for up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321252, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.