Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-17

Study Completion Date

2021-08-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model

NCT03707041

Malaria

COMPLETED PHASE1

First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants

NCT03261401

Healthy

COMPLETED PHASE1

Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

NCT01728701

Malaria Plasmodium Falciparum

COMPLETED PHASE1

Safety and Protective Efficacy of IV Immunization With Cryopreserved PfSPZ Under A/P Chemoprophylaxis

NCT02858817

Malaria

COMPLETED PHASE1

Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent

NCT02431650

Malaria

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early liver stage: Pooled Placebo

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.

Group Type PLACEBO_COMPARATOR

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

Palcebo

Intervention Type DRUG

Participants received single oral dose of placebo matched to M5717 capsule on Day 1.

Early liver stage: 30 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 30 mg

Intervention Type DRUG

Participants received 30 mg single oral dose of M5717 capsule on Day 1.

Early liver stage: 60 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 60 mg

Intervention Type DRUG

Participants received 60 mg single oral dose of M5717 capsule on Day 1.

Early liver stage: 80 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 80 mg

Intervention Type DRUG

Participants received 80 mg single oral dose of M5717 capsule on Day 1.

Early liver stage: 100 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 100 mg

Intervention Type DRUG

Participants received 100 mg single oral dose of M5717 capsule on Day 1.

Early liver stage: 200 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 200 mg

Intervention Type DRUG

Participants received 200 mg single oral dose of M5717 capsule on Day 1.

Late liver stage: Pooled Placebo

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

Placebo

Intervention Type DRUG

Participants received single oral dose of placebo matched to M5717 capsule on Day 5.

Late liver stage: 60 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 60 mg

Intervention Type DRUG

Participants received 60 mg single oral dose of M5717 capsule on Day 5.

Late liver stage: 100 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 100 mg

Intervention Type DRUG

Participants received 100 mg single oral dose of M5717 capsule on Day 5.

Late liver stage: 200 mg M5717

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.

Group Type EXPERIMENTAL

PfSPZ Challenge

Intervention Type BIOLOGICAL

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

M5717 200 mg

Intervention Type DRUG

Participants received 200 mg single oral dose of M5717 capsule on Day 5.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PfSPZ Challenge

Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.

Intervention Type BIOLOGICAL

Palcebo

Participants received single oral dose of placebo matched to M5717 capsule on Day 1.

Intervention Type DRUG

M5717 30 mg

Participants received 30 mg single oral dose of M5717 capsule on Day 1.

Intervention Type DRUG

M5717 60 mg

Participants received 60 mg single oral dose of M5717 capsule on Day 1.

Intervention Type DRUG

M5717 80 mg

Participants received 80 mg single oral dose of M5717 capsule on Day 1.

Intervention Type DRUG

M5717 100 mg

Participants received 100 mg single oral dose of M5717 capsule on Day 1.

Intervention Type DRUG

M5717 200 mg

Participants received 200 mg single oral dose of M5717 capsule on Day 1.

Intervention Type DRUG

Placebo

Participants received single oral dose of placebo matched to M5717 capsule on Day 5.

Intervention Type DRUG

M5717 60 mg

Participants received 60 mg single oral dose of M5717 capsule on Day 5.

Intervention Type DRUG

M5717 100 mg

Participants received 100 mg single oral dose of M5717 capsule on Day 5.

Intervention Type DRUG

M5717 200 mg

Participants received 200 mg single oral dose of M5717 capsule on Day 5.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes