HealthyPhase 1NCT04250363

Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

A Phase 1 study testing PfSPZ Challenge, Palcebo and M5717 30 mg in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.

Completed

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

Official record

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Trial summary

The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum sporozoite (PfSPZ) challenge in healthy participants. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: PfSPZ Challenge, Palcebo and M5717 30 mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteNetherlands
Study dates: 17 Feb 2020to 18 Aug 2021
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants who are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
Participants who have a body weight within 50 to 100 kilograms (kg) and body mass index within the range 19.0 to 29.9 kilograms per meter square (kg/m2) (inclusive)
Male participants, during the study intervention period and for at least 120 days after the day of the study intervention dose (covering a full sperm cycle of 90 days starting after 5 half lives of last dose of study intervention: - refrain from donating sperm plus, either - abstain from intercourse with a woman of childbearing potential (WOCBP) or - use a male condom, when having sexual intercourse with a WOCBP, who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of less than (<) 1 percent (%) per year, since a condom may break or leak
Female participants who are: - not a WOCBP; - at least 1 year post-menopausal (amenorrhea greater than or equal to [>=] 12 months and follicle-stimulating hormone [FSH] >= 40 milli-international units per milliliter [mIU/mL]) at screening; - surgically sterile (bilateral oophorectomy, hysterectomy or bilateral salpingectomy; tubal ligation alone is not sufficient)
Participants who are capable of giving signed informed consent, which includes compliance with the requirements (including mandatory intake of rescue medication to participants who have been administered the investigational Plasmodium falciparum sporozoite challenge) and restrictions listed in the informed consent form (ICF) and this protocol
Other protocol defined inclusion criteria could apply

Who cannot join

Participants with 12-Lead electrocardiogram (ECG) outside normal range (QTcF greater than [>] 450 milli seconds [ms], pulse rate [PR] > 215 ms, or QRS > 120 ms) and deemed clinically relevant by the Investigator
Supine systolic blood pressure > 140 or < 90 millimeter of mercury (mmHg), diastolic blood pressure > 90 or < 50 mmHg, and pulse rate > 90 or < 50 beats per minute (min) at screening and at admission on Day -1 (any abnormal blood pressure or pulse rate results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion)
Seropositive for human immunodeficiency virus (HIV) I and II antibody or antigen), hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV; antibody) tests
Liver function tests above the upper limit of normal (ULN) (> 3 x ULN) the day before DVI / study intervention administration (Day -1)
History or presence of diagnosed food or known drug allergies (including but not limited to allergy to any of the antimalarial rescue medications to be used in the study), or history of anaphylaxis or other severe allergic reactions
Participant with a whole blood donation or loss of > 450 mL within 60 days before administration of study drug or unwilling to defer blood donations for 6 months
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Leiden University Medical Center
Leiden

Other trials in Netherlands

About this study

Official title: A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants

Conditions: Healthy
Being tested: PfSPZ Challenge, Palcebo, M5717 30 mg, M5717 60 mg, M5717 80 mg
Keywords: Healthy Participants, M5717, Malaria, Plasmodium falciparum
Medical subject headings: Malaria, Malaria, Falciparum

What participants receive

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

PfSPZ ChallengeBiological
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
PalceboDrug
Participants received single oral dose of placebo matched to M5717 capsule on Day 1.
M5717 30 mgDrug
Participants received 30 mg single oral dose of M5717 capsule on Day 1.
M5717 60 mgDrug
Participants received 60 mg single oral dose of M5717 capsule on Day 1.
M5717 80 mgDrug
Participants received 80 mg single oral dose of M5717 capsule on Day 1.
M5717 100 mgDrug
Participants received 100 mg single oral dose of M5717 capsule on Day 1.
M5717 200 mgDrug
Participants received 200 mg single oral dose of M5717 capsule on Day 1.
PlaceboDrug
Participants received single oral dose of placebo matched to M5717 capsule on Day 5.
M5717 60 mgDrug
Participants received 60 mg single oral dose of M5717 capsule on Day 5.
M5717 100 mgDrug
Participants received 100 mg single oral dose of M5717 capsule on Day 5.
M5717 200 mgDrug
Participants received 200 mg single oral dose of M5717 capsule on Day 5.

Study groups in NCT04250363
Study group	Role	What they receive
Early liver stage: Pooled Placebo	Placebo comparator	Participants received single dose of placebo matched to M5717 capsule on Day 1 after 2 hours of Plasmodium falciparum Sporozoite (PfSPZ) (3200 sporozoites per injection) intravenous (IV) inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: Palcebo
Early liver stage: 30 mg M5717	Experimental	Participants received single dose of M5717 30 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 30 mg
Early liver stage: 60 mg M5717	Experimental	Participants received single dose of M5717 60 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 60 mg
Early liver stage: 80 mg M5717	Experimental	Participants received single dose of M5717 80 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 80 mg
Early liver stage: 100 mg M5717	Experimental	Participants received single dose of M5717 100 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 100 mg
Early liver stage: 200 mg M5717	Experimental	Participants received single dose of M5717 200 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 200 mg
Late liver stage: Pooled Placebo	Experimental	Participants received single dose of placebo matched to M5717 capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: Placebo
Late liver stage: 60 mg M5717	Experimental	Participants received single dose of M5717 60 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 60 mg
Late liver stage: 100 mg M5717	Experimental	Participants received single dose of M5717 100 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 100 mg
Late liver stage: 200 mg M5717	Experimental	Participants received single dose of M5717 200 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1. Receives: Biological: PfSPZ Challenge; Drug: M5717 200 mg

What is being measured

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

Early Liver Stage: Number of Participants Over Time With Positive Parasitemia
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Measured: Early Liver Stage: From Day 1 up to Day 28
Late Liver Stage: Number of Participants Over Time With Positive Parasitemia
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Measured: Late Liver Stage: From Day 5 up to Day 32
Early Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
Measured: Early Liver Stage: From Day 1 up to Day 28
Late Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
Measured: Late Liver Stage: From Day 5 up to Day 32
Early Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
Measured: Early Liver Stage: From Day 1 up to Day 28
Late Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
Measured: Late Liver Stage: From Day 5 up to Day 32
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
Measured: Early Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26 and 28
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
Measured: Late Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 28, 30 and 32
Dose Exposure Response Relationship of M5717 Assessed by Logistic Regression Model
Exposure efficacy relationship was analyzed using logistic regression model. Different exposure matrices (AUC0-24, AUC0-168, AUC0-inf, C24 and C168) were analyzed using logistic regression model.
Measured: From Day 5 up to Day 32

Secondary outcomes (17)

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE was defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to study intervention.
Measured: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity
Severity of adverse events (AE) were assessed by the investigator per the Qualitative Toxicity Scale. Grade 1= Mild, Grade 2=Moderate, Grade 3=Severe. The number of participants that experienced at least one solicited local TEAE were summarized by grade. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs include both Serious TEAEs and non-serious TEAEs. Number of participants with Grade=1, Grade=2 and 3 were reported.
Measured: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Laboratory assessments included hematology, biochemistry, urinalysis, and coagulation. Number of participants with clinically significant changes from baseline in laboratory values which were deemed clinically significant by the investigator were reported.
Measured: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs included oral body temperature, height, weight, systolic blood pressure, diastolic blood pressure, and pulse rate. Number of participants with clinically significant changes from baseline in Vital signs which were deemed clinically significant by the investigator were reported.
Measured: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Single 12-lead ECG was obtained as outlined using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals. Number of participants with clinically significant changes from baseline in ECG which were deemed clinically significant by the investigator were reported.
Measured: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717
AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717
Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717
AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to 168 Hours Post-dose (AUC 0-168) of M5717
AUC from time zero to 168 hours post dose. Calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120 and 168 hours post-dose
Maximum Observed Blood Concentration (Cmax) of M5717
Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Blood Concentration at 24 Hours (C24) of M5717
Blood samples for PK analysis of C24 of M5717 was reported.
Measured: At 24 hours post-dose
Blood Concentration at 168 Hours (C168) of M5717
C168 is the calculated blood concentration at 168 hours post-dose at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ).
Measured: At 168 hours post-dose
Time to Reach Maximum Blood Concentration (Tmax) of M5717
Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Terminal Half-life (t1/2) of M5717
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Elimination Rate Constant (Lambda z) of M5717
Elimination rate constant determined from the terminal slope of the log-transformed concentration curve using linear regression on terminal data points of the curve.
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Total Body Clearance From Blood (CL/f) of M5717
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717
The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf) multiply Lambda(z).
Measured: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Timeline

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

17 Feb 202018 Aug 2021

First posted31 Jan 2020
Study start17 Feb 2020
Primary completion18 Aug 2021
Study completion18 Aug 2021

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 HealthyStudies of the same condition, open and under way.
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: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04250363
Sponsor's protocol ID: MS201618_0003
Other IDs: 2019-003414-14, 203481/Z/16/Z, 2019
Status last verified: Nov 2023
First submitted: 29 Jan 2020
Last updated: 1 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

van der Plas JL, Kuiper VP, Bagchus WM, Bodding M, Yalkinoglu O, Tappert A, Seitzinger A, Spangenberg T, Bezuidenhout D, Wilkins J, Oeuvray C, Dhingra SK, Thathy V, Fidock DA, Smidt LCA, Roozen GVT, Koopman JPR, Lamers OAC, Sijtsma J, van Schuijlenburg R, Wessels E, Meij P, Kamerling IMC, Roestenberg M, Khandelwal A. Causal chemoprophylactic activity of cabamiquine against Plasmodium falciparum in a controlled human malaria infection: a randomised, double-blind, placebo-controlled study in the Netherlands. Lancet Infect Dis. 2023 Oct;23(10):1164-1174. doi: 10.1016/S1473-3099(23)00212-8. Epub 2023 Jul 3.
PubMed 37414066

Want to know more?

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

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Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants
ClinicalTrials.gov ID: NCT04250363
Acronym / sponsor ID: MS201618_0003
Conditions: Healthy
Keywords: Healthy Participants, M5717, Malaria, Plasmodium falciparum
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 17 Feb 2020 (actual)
Primary completion: 18 Aug 2021 (actual)
Study completion: 18 Aug 2021 (actual)
First posted: 31 Jan 2020 (actual)
Results: Posted 1 May 2024

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Early liver stage: Pooled Placebo	Placebo comparator	Biological: PfSPZ Challenge, Drug: PalceboParticipants received single dose of placebo matched to M5717 capsule on Day 1 after 2 hours of Plasmodium falciparum Sporozoite (PfSPZ) (3200 sporozoites per injection) intravenous (IV) inoculation administration on Day 1.
Early liver stage: 30 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 30 mgParticipants received single dose of M5717 30 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Early liver stage: 60 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 60 mgParticipants received single dose of M5717 60 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Early liver stage: 80 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 80 mgParticipants received single dose of M5717 80 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Early liver stage: 100 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 100 mgParticipants received single dose of M5717 100 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Early liver stage: 200 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 200 mgParticipants received single dose of M5717 200 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Late liver stage: Pooled Placebo	Experimental	Biological: PfSPZ Challenge, Drug: PlaceboParticipants received single dose of placebo matched to M5717 capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Late liver stage: 60 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 60 mgParticipants received single dose of M5717 60 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Late liver stage: 100 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 100 mgParticipants received single dose of M5717 100 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
Late liver stage: 200 mg M5717	Experimental	Biological: PfSPZ Challenge, Drug: M5717 200 mgParticipants received single dose of M5717 200 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Participants who are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
Participants who have a body weight within 50 to 100 kilograms (kg) and body mass index within the range 19.0 to 29.9 kilograms per meter square (kg/m2) (inclusive)
Male participants, during the study intervention period and for at least 120 days after the day of the study intervention dose (covering a full sperm cycle of 90 days starting after 5 half lives of last dose of study intervention: - refrain from donating sperm plus, either - abstain from intercourse with a woman of childbearing potential (WOCBP) or - use a male condom, when having sexual intercourse with a WOCBP, who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of less than (<) 1 percent (%) per year, since a condom may break or leak
Female participants who are: - not a WOCBP; - at least 1 year post-menopausal (amenorrhea greater than or equal to [>=] 12 months and follicle-stimulating hormone [FSH] >= 40 milli-international units per milliliter [mIU/mL]) at screening; - surgically sterile (bilateral oophorectomy, hysterectomy or bilateral salpingectomy; tubal ligation alone is not sufficient)
Participants who are capable of giving signed informed consent, which includes compliance with the requirements (including mandatory intake of rescue medication to participants who have been administered the investigational Plasmodium falciparum sporozoite challenge) and restrictions listed in the informed consent form (ICF) and this protocol

Key exclusion criteria (7 listed)

Participants with 12-Lead electrocardiogram (ECG) outside normal range (QTcF greater than [>] 450 milli seconds [ms], pulse rate [PR] > 215 ms, or QRS > 120 ms) and deemed clinically relevant by the Investigator
Supine systolic blood pressure > 140 or < 90 millimeter of mercury (mmHg), diastolic blood pressure > 90 or < 50 mmHg, and pulse rate > 90 or < 50 beats per minute (min) at screening and at admission on Day -1 (any abnormal blood pressure or pulse rate results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion)
Seropositive for human immunodeficiency virus (HIV) I and II antibody or antigen), hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV; antibody) tests
Liver function tests above the upper limit of normal (ULN) (> 3 x ULN) the day before DVI / study intervention administration (Day -1)
History or presence of diagnosed food or known drug allergies (including but not limited to allergy to any of the antimalarial rescue medications to be used in the study), or history of anaphylaxis or other severe allergic reactions

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
PfSPZ ChallengeParticipants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.	Biological	Early liver stage: 100 mg M5717, Early liver stage: 200 mg M5717, Early liver stage: 30 mg M5717, Early liver stage: 60 mg M5717, Early liver stage: 80 mg M5717, Early liver stage: Pooled Placebo, Late liver stage: 100 mg M5717, Late liver stage: 200 mg M5717, Late liver stage: 60 mg M5717, Late liver stage: Pooled Placebo
PalceboParticipants received single oral dose of placebo matched to M5717 capsule on Day 1.	Drug	Early liver stage: Pooled Placebo
M5717 30 mgParticipants received 30 mg single oral dose of M5717 capsule on Day 1.	Drug	Early liver stage: 30 mg M5717
M5717 60 mgParticipants received 60 mg single oral dose of M5717 capsule on Day 1.	Drug	Early liver stage: 60 mg M5717
M5717 80 mgParticipants received 80 mg single oral dose of M5717 capsule on Day 1.	Drug	Early liver stage: 80 mg M5717
M5717 100 mgParticipants received 100 mg single oral dose of M5717 capsule on Day 1.	Drug	Early liver stage: 100 mg M5717
M5717 200 mgParticipants received 200 mg single oral dose of M5717 capsule on Day 1.	Drug	Early liver stage: 200 mg M5717
PlaceboParticipants received single oral dose of placebo matched to M5717 capsule on Day 5.	Drug	Late liver stage: Pooled Placebo
M5717 60 mgParticipants received 60 mg single oral dose of M5717 capsule on Day 5.	Drug	Late liver stage: 60 mg M5717
M5717 100 mgParticipants received 100 mg single oral dose of M5717 capsule on Day 5.	Drug	Late liver stage: 100 mg M5717
M5717 200 mgParticipants received 200 mg single oral dose of M5717 capsule on Day 5.	Drug	Late liver stage: 200 mg M5717

Primary outcome

Early Liver Stage: Number of Participants Over Time With Positive Parasitemia
Time frame: Early Liver Stage: From Day 1 up to Day 28
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Late Liver Stage: Number of Participants Over Time With Positive Parasitemia
Time frame: Late Liver Stage: From Day 5 up to Day 32
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
Early Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time frame: Early Liver Stage: From Day 1 up to Day 28
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
Late Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time frame: Late Liver Stage: From Day 5 up to Day 32
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
Early Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Time frame: Early Liver Stage: From Day 1 up to Day 28
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
Late Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Time frame: Late Liver Stage: From Day 5 up to Day 32
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
Time frame: Early Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26 and 28
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
Time frame: Late Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 28, 30 and 32
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension. The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms). Total scores are reported here.
Dose Exposure Response Relationship of M5717 Assessed by Logistic Regression Model
Time frame: From Day 5 up to Day 32
Exposure efficacy relationship was analyzed using logistic regression model. Different exposure matrices (AUC0-24, AUC0-168, AUC0-inf, C24 and C168) were analyzed using logistic regression model.

17 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity
Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
Area Under the Blood Concentration-Time Curve From Time Zero to 168 Hours Post-dose (AUC 0-168) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120 and 168 hours post-dose
Maximum Observed Blood Concentration (Cmax) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Blood Concentration at 24 Hours (C24) of M5717
Time frame: At 24 hours post-dose
Blood Concentration at 168 Hours (C168) of M5717
Time frame: At 168 hours post-dose
Time to Reach Maximum Blood Concentration (Tmax) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Terminal Half-life (t1/2) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Elimination Rate Constant (Lambda z) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Total Body Clearance From Blood (CL/f) of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717
Time frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose

Results and safety

Results posted to the registry on 1 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Liver Stage: Pooled Placebo	6	6
Early Liver Stage: 30 mg M5717	3	3
Early Liver Stage: 60 mg M5717	6	6
Early Liver Stage: 80 mg M5717	6	6
Early Liver Stage: 100 mg M5717	3	3
Early Liver Stage: 200 mg M5717	3	3
Late Liver Stage: Pooled Placebo	3	3
Late Liver Stage: 60 mg M5717	3	3
Late Liver Stage: 100 mg M5717	3	3
Late Liver Stage: 200 mg M5717	3	3

Primary outcome: Early Liver Stage: Number of Participants Over Time With Positive Parasitemia

Time frame: Early Liver Stage: From Day 1 up to Day 28. Count of participants. Unit: Participants

Measure	Early Liver Stage: Pooled Placebo n = 6	Early Liver Stage: 30 mg M5717 n = 3	Early Liver Stage: 60 mg M5717 n = 6	Early Liver Stage: 80 mg M5717 n = 6	Early Liver Stage: 100 mg M5717 n = 3	Early Liver Stage: 200 mg M5717 n = 3
Value	6	3	2	1	0	0

Population analysed: Per-protocol (PP) analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

Primary outcome: Late Liver Stage: Number of Participants Over Time With Positive Parasitemia

Time frame: Late Liver Stage: From Day 5 up to Day 32. Count of participants. Unit: Participants

Measure	Late Liver Stage: Pooled Placebo n = 3	Late Liver Stage: 60 mg M5717 n = 3	Late Liver Stage: 100 mg M5717 n = 3	Late Liver Stage: 200 mg M5717 n = 3
Value	3	0	0	0

Population analysed: PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study.

Primary outcome: Early Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)

Time frame: Early Liver Stage: From Day 1 up to Day 28. Median (Full Range). Unit: Days

Measure	Early Liver Stage: Pooled Placebo n = 6	Early Liver Stage: 30 mg M5717 n = 3	Early Liver Stage: 60 mg M5717 n = 2	Early Liver Stage: 80 mg M5717 n = 1	Early Liver Stage: 100 mg M5717 n = 0	Early Liver Stage: 200 mg M5717 n = 0
Value	10.0 (9 to 12)	15.0 (15 to 18)	22.0 (20 to 24)	24.0 (24 to 24)	–	–

Population analysed: PP analysis set included all SAF participants who comply with the protocol and meet no criteria that could impact the proper evaluation of key objectives of the study. Here, "Overall Number of Participants Analyzed" signifies those participants who had positive parasitemia.

Primary outcome: Late Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)

Time frame: Late Liver Stage: From Day 5 up to Day 32. Median (Full Range). Unit: Days

Measure	Late Liver Stage: Pooled Placebo n = 3	Late Liver Stage: 60 mg M5717 n = 0	Late Liver Stage: 100 mg M5717 n = 0	Late Liver Stage: 200 mg M5717 n = 0
Value	10.0 (9 to 11)	–	–	–

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Liver Stage: Pooled Placebo	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Early Liver Stage: 30 mg M5717	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Early Liver Stage: 60 mg M5717	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Early Liver Stage: 80 mg M5717	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Early Liver Stage: 100 mg M5717	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Early Liver Stage: 200 mg M5717	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Late Liver Stage: Pooled Placebo	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Late Liver Stage: 60 mg M5717	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Late Liver Stage: 100 mg M5717	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Late Liver Stage: 200 mg M5717	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37414066van der Plas JL, Kuiper VP, Bagchus WM, Bodding M, Yalkinoglu O, Tappert A, Seitzinger A, Spangenberg T, Bezuidenhout D, Wilkins J, Oeuvray C, Dhingra SK, Thathy V, Fidock DA, Smidt LCA, Roozen GVT, Koopman JPR, Lamers OAC, Sijtsma J, van Schuijlenburg R, Wessels E, Meij P, Kamerling IMC, Roestenberg M, Khandelwal A. Causal chemoprophylactic activity of cabamiquine against Plasmodium falciparum in a controlled human malaria infection: a randomised, double-blind, placebo-controlled study in the Netherlands. Lancet Infect Dis. 2023 Oct;23(10):1164-1174. doi: 10.1016/S1473-3099(23)00212-8. Epub 2023 Jul 3.
Trial Awareness and Transparency websiteLink provided by the sponsor.
Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

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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.

Medical Responsible study director

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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 1 May 2024. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 1 May 2024). 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?

Early Liver Stage: Number of Participants Over Time With Positive Parasitemia (time frame: Early Liver Stage: From Day 1 up to Day 28). The study lists 9 primary outcomes in all. 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 NCT04250363, 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 1 May 2024.