Plasmodium Falciparum, MalariaPhase 1NCT02450578
DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria
A Phase 1 study testing DSM265 400mg, Plasmodium falciparum sporozoite challenge and Malarone in people with Plasmodium Falciparum, Malaria, run by Medicines for Malaria Venture at 1 site in Germany.
Trial summary
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum, Malaria
- What is being tested?
- DSM265 400mg, Plasmodium falciparum sporozoite challenge and Malarone
- 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
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Apr 2016
- 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
- Good health based on medical history and physical examination- Body mass index >18 and <30 kg/m2
- Lab results without clinically significant findings in 28 days prior to enrolment
- Negative drug screening test
- Females: negative pregnancy test at screening and on the day before first dose of DSM265 and sporozoite challenge injection
- Sexually active males must agree to use a medically acceptable form of contraception from enrolment and continue for 12 weeks after the dose of DSM265
- Women may only be included if they are either Identified as not of child bearing potential, or if of child bearing potential and willing and able to practice one of the continuous acceptable methods of contraception (must be one with failure rate less than 1% per year) with double barrier protection:
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- Intrauterine device+condoms,
- Diaphragms+spermicidal gel/foam+condoms,
- Hormonal contraceptives (oral, depot, patch, injectable or vaginal ring) stabilized for at least 30 days before the study drug + condoms from screening to at least 60 days after dose of DSM265
- Agree to allow the investigators to discuss the medical history with General Practitioner and to sign a request to release medical information concerning contra-indications for participation in the study
- Able and willing to comply with all study requirements for the duration of the study
- Agree to undergo all study procedures, to attend all study visits and stay overnight for observation if required, up to last follow up visit
- Willing to undergo a sporozoite challenge
- Able and willing to answer all questions on the informed consent quiz correctly demonstrating an understanding of the meaning and of the study procedures
- Able and willing to sign the informed consent form
- Reachable (24/7) by mobile phone or email during the whole study period
- Agree to refrain from blood donation during the course of the study and after the end of involvement in the study according to the local and national blood banking eligibility criteria (currently 4 years in Germany)
- Willing to take a curative regimen of Riamet or another registered antimalarial if necessary
Who cannot join
- Any history of malaria
- Plans to travel to malaria endemic region during the study period up to last follow up visit or plans to travel outside of Germany during the challenge period
- unable to be closely followed for social, geographic or psychological reasons
- Previous participation in any malaria vaccine study or controlled human malaria infection study
- Participation in any other clinical study within 30 days before enrolment in the study, or plan to participate in another investigational vaccine/drug research during the study period.
- Woman who is breast-feeding or planning to become pregnant during the study
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- Positive human immunodeficiency virus, seropositive for hepatitis B surface antigen or Hepatitis C virus tests
- Any confirmed/suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus infection, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the 6 months before enrolment (inhaled and topical steroids are allowed)
- History of serious psychiatric condition that may affect participation in the study, precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within 5 years prior to enrolment, history of a suicide plan or attempt.
- History of convulsions or severe head trauma
- Symptoms, physical signs and lab values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, and other conditions which could interfere with the interpretation of the study results or compromise health
- History of cancer (except basal cell carcinoma of the skin), or diabetes mellitus or of arrhythmias or documented prolonged QTF-interval (>450msec)
- Clinically significant abnormalities in electrocardiogram at screening: pathologic Q wave, prolonged QT interval, and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block (type 2 or type 3)
- In moderate risk or higher categories for fatal or non-fatal cardiovascular event within 5 years (>10%) determined by non-invasive criteria for cardiac risk
- Positive family history in relatives <50 years for cardiac disease
- History of psoriasis or porphyria, which may be exacerbated by chloroquine
- History of splenectomy
- Sickle cell anaemia or other red blood cell disorders
- History of allergy or contra-indications to or having contraindications to the use of chloroquine phosphate, atovaquone-proguanil (cohort 1B), artemether or lumefantrine
- Use of any prescription drugs (except contraception), herbal supplements or over-the-counter medication in 4 weeks before dosing or 5x half-lives, whichever is longer
- Use or anticipated use of medications known to cause drug reactions with rescue medications or Malarone, such as cimetidine, metoclopramide, antacids and taken at any point during the study period.
- Intake of grapefruit, grapefruit juice, Seville orange or other products containing these ingredients within 7 days of the first drug administration
- Use of chronic immunosuppressive drugs, or other immune modifying drugs within 6 months of enrolment (inhaled and topical corticosteroids and oral anti-histaminic are allowed) and/or during the study period
- Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin ) and/or during the study period
- Use of immunoglobulins or blood products in 3 months prior to enrolment
- Suspected/known injecting drug abuse in 5 years preceding enrolment
- Current smoking more than 10 cigarettes or equivalent per day
- Plan for major surgery between enrolment and follow up
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Tübingen, Institut für Tropenmedizin
Tübingen, 72074
About this study
Official title: Evaluation of the Prophylactic Antimalarial Activity of a Single Dose of DSM265 in Non-immune Healthy Adult Volunteers by Controlled Human Malaria Infection With PfSPZ Challenge
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.
Read the detailed description
This study follows the First In Human dose-escalation study of DSM265 (25 - 800 mg of DSM265) and an Induced-Blood Stage Malaria Challenge study (150 mg of DSM265) conducted in healthy adult volunteers in Australia. After identification of efficacious DSM265 plasma concentrations in the Induced-Blood Stage Malaria model, the current study will evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites (Challenge).
Three sequential cohorts of healthy male and women volunteers, of non-childbearing potential or of childbearing potential with predefined accepted methods of contraception, are planned in order to investigate three preventive conditions with regard to administration of DSM265. Preventive administration of the study drug will occur 1 and 7 days before inoculum of Plasmodium falciparum sporozoite Challenge, with a last cohort administered at a time point to be determined from the 2 previous cohorts but which will not exceed 28 days before the challenge. The study will also include a cohort where subjects will be treated with atovaquone-proguanil (Malarone®) using the approved regimen for chemoprophylaxis.
- Conditions
- Plasmodium Falciparum, Malaria
- Being tested
- DSM265 400mg, Placebo to DSM265 400 mg, Plasmodium falciparum sporozoite challenge, Malarone
- Keywords
- Malaria, Plasmodium falciparum sporozoite challenge, DSM265
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM265 400mgDrug
DSM265 400mg, single oral administration in a fed state
Placebo to DSM265 400 mgDrug
Placebo to DSM265 400mg, single oral administration in a fed state
Plasmodium falciparum sporozoite challengeBiological
Also called Sporozoite inoculum
IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation
MalaroneDrug
Also called atovaquone / proguanil hydrochloride
250 mg atovaquone, 100 mg proguanil hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a: DSM265/placebo, sporozoite inoculum | Experimental | DSM265 400mg / placebo Day -1, sporozoite inoculum Day 0 Receives: Drug: DSM265 400mg; Drug: Placebo to DSM265 400 mg; Biological: Plasmodium falciparum sporozoite challenge |
| Cohort 1b: Malarone, sporozoite inoculum | Active comparator | Malarone daily for 9 days from Day -1 to Day 7, sporozoite inoculum Day 0 Receives: Biological: Plasmodium falciparum sporozoite challenge; Drug: Malarone |
| Cohort 2: DSM265/placebo, sporozoite inoculum | Experimental | DSM265 400mg / placebo Day -7, sporozoite inoculum Day 0 Receives: Drug: DSM265 400mg; Drug: Placebo to DSM265 400 mg; Biological: Plasmodium falciparum sporozoite challenge |
| Cohort 3: DSM265 / placebo, sporozoite inoculum (Optional) | Experimental | DSM265 400mg / placebo Day -X, sporozoite inoculum Day 0 Receives: Drug: DSM265 400mg; Drug: Placebo to DSM265 400 mg; Biological: Plasmodium falciparum sporozoite challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
The infection rate is the number (percentage) of subjects in a cohort who became positive for parasitemia.
Complete protection = Subjects with pre-patent period equal to 28 days.
Measured: Day 0 to Day 28 post-inoculum (daily)
Pre-patent Period
The pre-patent period is defined as the time (days) from inoculation with PfSPZ to first occurrence of a positive TBS. If no positive TBS is seen by Day 28, this variable is set to 28 days.
Complete protection = Subjects showing with pre-patent period equal to 28 days.
Measured: Day 0 to Day 28 post-inoculum (daily)
Secondary outcomes (14)
Number of Participants With Adverse Events as a Measure of Safety & Tolerability of DSM265
Safety \& tolerability of DSM265 for causal and suppressive chemoprophylaxis in non-immune healthy volunteers in a non-immune healthy volunteers in CHMI with PfSPZ challenge.
Measured: From first dose (Day -1 in Cohort 1A and Day -7 in Cohort 2) to Day 60 post-inoculum
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety & Tolerability of Malarone
Safety \& tolerability of Malarone for causal and suppressive chemoprophylaxis in non-immune healthy volunteers in a Plasmodium falciparum sporozoite challenge. Measured by adverse events, laboratory data.
Malarone® was administered as a single daily dose over a period of 9 days from Day -1 to Day 7.
Measured: From first dose (Day -1, Cohort 1b) to Day 60 post-inoculum
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Plasmodium Falciparum Sporozoite Challenge Inoculum
Safety \& tolerability of Plasmodium falciparum sporozoite challenge inoculum during DSM265 administration, and Malarone administration. Measured by adverse events, laboratory data
Measured: Day 0 to Day 60 post-inoculum
DSM265 Pharmacokinetics Profile - T Max
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - T 1/2
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - C Max
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - AUC 0-∞, AUC 0-168h, and AUC 0-480h
Pre-dose and post-dose during the period including Day 28 for AUC 0-∞, AUC 0-168h, and AUC 0-480h
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - CL/F
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - Vz/F
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - T Max
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - Cmax
Pre-dose and post-dose during the period including Day 28
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - AUC 0-t, AUC 0-168h, and AUC 0-480h
Pre-dose and post-dose during the period including Day 28 for AUC 0-t, AUC 0-168h, and AUC 0-480h
Measured: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
The Pharmacokinetic-pharmacodynamic Profile of Pre-administration of DSM265 on Clearance of Plasmodium Falciparum Parasites After Administration of the Sporozoite Challenge
The profile of plasma concentrations and pharmacokinetic parameters (AUC, Cmax, Tmax, T0-inf, AUC0-t, t1/2) will be reviewed on a background of the safety profile (adverse events, laboratory and ECG data) and the clearance of Plasmodium falciparum parasites (efficacy) after administration of the sporozoite challenge
Measured: From first dose of DSM265 (Day -1 in Cohort 1a, Day -7 in Cohort 2 and Day -X in Cohort 3) to 480 hours post-dose
Recrudescence of Parasite Kinetics Following DSM265 Administration.
On any re-appearance of parasites, thick smears and PCR samples will be examined to determine whether the parasite is a different variant(recrudescence) or has the same genetic profile as the original infection (re-infection) post-dose
Measured: Day 6 post-inoculum to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
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 Plasmodium Falciparum, MalariaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen
- Responsible party
- Sponsor
- Investigators
- Benjamin Mordmüller, Dr. med, Principal investigator, Institut für Tropenmedizin, Uni. of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450578
- Sponsor's protocol ID
- MMV_DSM265_14_01
- Status last verified
- Jan 2021
- First submitted
- 16 Mar 2015
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sulyok M, Ruckle T, Roth A, Murbeth RE, Chalon S, Kerr N, Samec SS, Gobeau N, Calle CL, Ibanez J, Sulyok Z, Held J, Gebru T, Granados P, Bruckner S, Nguetse C, Mengue J, Lalremruata A, Sim BKL, Hoffman SL, Mohrle JJ, Kremsner PG, Mordmuller B. DSM265 for Plasmodium falciparum chemoprophylaxis: a randomised, double blinded, phase 1 trial with controlled human malaria infection. Lancet Infect Dis. 2017 Jun;17(6):636-644. doi: 10.1016/S1473-3099(17)30139-1. Epub 2017 Mar 28.
PubMed 28363637
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prophylactic Antimalarial Activity of a Single Dose of DSM265 in Non-immune Healthy Adult Volunteers by Controlled Human Malaria Infection With PfSPZ Challenge
- ClinicalTrials.gov ID
- NCT02450578
- Acronym / sponsor ID
- MMV_DSM265_14_01
- Conditions
- Plasmodium Falciparum, Malaria
- Keywords
- Malaria, Plasmodium falciparum sporozoite challenge, DSM265
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen
- Study start
- Oct 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites.
Detailed description
This study follows the First In Human dose-escalation study of DSM265 (25 - 800 mg of DSM265) and an Induced-Blood Stage Malaria Challenge study (150 mg of DSM265) conducted in healthy adult volunteers in Australia. After identification of efficacious DSM265 plasma concentrations in the Induced-Blood Stage Malaria model, the current study will evaluate the efficacy of DSM265 as a causal prophylactic in a standardized and validated Human Challenge model using direct venous inoculation of aseptic, purified, cryopreserved, vialed Plasmodium falciparum sporozoites (Challenge).
Three sequential cohorts of healthy male and women volunteers, of non-childbearing potential or of childbearing potential with predefined accepted methods of contraception, are planned in order to investigate three preventive conditions with regard to administration of DSM265. Preventive administration of the study drug will occur 1 and 7 days before inoculum of Plasmodium falciparum sporozoite Challenge, with a last cohort administered at a time point to be determined from the 2 previous cohorts but which will not exceed 28 days before the challenge. The study will also include a cohort where subjects will be treated with atovaquone-proguanil (Malarone®) using the approved regimen for chemoprophylaxis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a: DSM265/placebo, sporozoite inoculum | Experimental | Drug: DSM265 400mg, Drug: Placebo to DSM265 400 mg, Biological: Plasmodium falciparum sporozoite challengeDSM265 400mg / placebo Day -1, sporozoite inoculum Day 0 |
| Cohort 1b: Malarone, sporozoite inoculum | Active comparator | Biological: Plasmodium falciparum sporozoite challenge, Drug: MalaroneMalarone daily for 9 days from Day -1 to Day 7, sporozoite inoculum Day 0 |
| Cohort 2: DSM265/placebo, sporozoite inoculum | Experimental | Drug: DSM265 400mg, Drug: Placebo to DSM265 400 mg, Biological: Plasmodium falciparum sporozoite challengeDSM265 400mg / placebo Day -7, sporozoite inoculum Day 0 |
| Cohort 3: DSM265 / placebo, sporozoite inoculum (Optional) | Experimental | Drug: DSM265 400mg, Drug: Placebo to DSM265 400 mg, Biological: Plasmodium falciparum sporozoite challengeDSM265 400mg / placebo Day -X, sporozoite inoculum Day 0 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Good health based on medical history and physical examination- Body mass index >18 and <30 kg/m2
- Lab results without clinically significant findings in 28 days prior to enrolment
- Negative drug screening test
- Females: negative pregnancy test at screening and on the day before first dose of DSM265 and sporozoite challenge injection
- Sexually active males must agree to use a medically acceptable form of contraception from enrolment and continue for 12 weeks after the dose of DSM265
Key exclusion criteria (28 listed)
- Any history of malaria
- Plans to travel to malaria endemic region during the study period up to last follow up visit or plans to travel outside of Germany during the challenge period
- unable to be closely followed for social, geographic or psychological reasons
- Previous participation in any malaria vaccine study or controlled human malaria infection study
- Participation in any other clinical study within 30 days before enrolment in the study, or plan to participate in another investigational vaccine/drug research during the study period.
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 |
|---|---|---|
| DSM265 400mgDSM265 400mg, single oral administration in a fed state | Drug | Cohort 1a: DSM265/placebo, sporozoite inoculum, Cohort 2: DSM265/placebo, sporozoite inoculum, Cohort 3: DSM265 / placebo, sporozoite inoculum (Optional) |
| Placebo to DSM265 400 mgPlacebo to DSM265 400mg, single oral administration in a fed state | Drug | Cohort 1a: DSM265/placebo, sporozoite inoculum, Cohort 2: DSM265/placebo, sporozoite inoculum, Cohort 3: DSM265 / placebo, sporozoite inoculum (Optional) |
| Plasmodium falciparum sporozoite challengeAlso: Sporozoite inoculumIV Plasmodium falciparum sporozoites (3200) by direct venous inoculation | Biological | Cohort 1a: DSM265/placebo, sporozoite inoculum, Cohort 1b: Malarone, sporozoite inoculum, Cohort 2: DSM265/placebo, sporozoite inoculum, Cohort 3: DSM265 / placebo, sporozoite inoculum (Optional) |
| MalaroneAlso: atovaquone / proguanil hydrochloride250 mg atovaquone, 100 mg proguanil hydrochloride | Drug | Cohort 1b: Malarone, sporozoite inoculum |
Primary outcome
Infection Rate
Time frame: Day 0 to Day 28 post-inoculum (daily)
The infection rate is the number (percentage) of subjects in a cohort who became positive for parasitemia. Complete protection = Subjects with pre-patent period equal to 28 days.
Pre-patent Period
Time frame: Day 0 to Day 28 post-inoculum (daily)
The pre-patent period is defined as the time (days) from inoculation with PfSPZ to first occurrence of a positive TBS. If no positive TBS is seen by Day 28, this variable is set to 28 days. Complete protection = Subjects showing with pre-patent period equal to 28 days.
14 secondary outcomes
Number of Participants With Adverse Events as a Measure of Safety & Tolerability of DSM265
Time frame: From first dose (Day -1 in Cohort 1A and Day -7 in Cohort 2) to Day 60 post-inoculum
Number of Participants With Treatment Emergent Adverse Events (TEAE) as a Measure of Safety & Tolerability of Malarone
Time frame: From first dose (Day -1, Cohort 1b) to Day 60 post-inoculum
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Plasmodium Falciparum Sporozoite Challenge Inoculum
Time frame: Day 0 to Day 60 post-inoculum
DSM265 Pharmacokinetics Profile - T Max
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - T 1/2
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - C Max
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - AUC 0-∞, AUC 0-168h, and AUC 0-480h
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - CL/F
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM265 Pharmacokinetics Profile - Vz/F
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - T Max
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - Cmax
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
DSM450 Pharmacokinetics Profile - AUC 0-t, AUC 0-168h, and AUC 0-480h
Time frame: From pre-dose of DSM265 (Day -1 in Cohort 1a and Day -7 in Cohort 2) to Day 28 post-inoculum
The Pharmacokinetic-pharmacodynamic Profile of Pre-administration of DSM265 on Clearance of Plasmodium Falciparum Parasites After Administration of the Sporozoite Challenge
Time frame: From first dose of DSM265 (Day -1 in Cohort 1a, Day -7 in Cohort 2 and Day -X in Cohort 3) to 480 hours post-dose
Recrudescence of Parasite Kinetics Following DSM265 Administration.
Time frame: Day 6 post-inoculum to Day 60
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28363637Sulyok M, Ruckle T, Roth A, Murbeth RE, Chalon S, Kerr N, Samec SS, Gobeau N, Calle CL, Ibanez J, Sulyok Z, Held J, Gebru T, Granados P, Bruckner S, Nguetse C, Mengue J, Lalremruata A, Sim BKL, Hoffman SL, Mohrle JJ, Kremsner PG, Mordmuller B. DSM265 for Plasmodium falciparum chemoprophylaxis: a randomised, double blinded, phase 1 trial with controlled human malaria infection. Lancet Infect Dis. 2017 Jun;17(6):636-644. doi: 10.1016/S1473-3099(17)30139-1. Epub 2017 Mar 28.
- Individual participant dataSharing planned: No
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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.
Benjamin Mordmüller, Dr. med principal investigator
Institut für Tropenmedizin, Uni. of Tübingen
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 DSM265 400mg, Plasmodium falciparum sporozoite challenge and Malarone in people with Plasmodium Falciparum, Malaria, run by Medicines for Malaria Venture at 1 site in Germany.
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 18 inclusion and 28 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 Jan 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 Germany. 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 3 Dec 2020). 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?
Infection Rate (time frame: Day 0 to Day 28 post-inoculum (daily)). The study lists 2 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 NCT02450578, 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 Jan 2021.