HealthyPhase 1NCT02562872
DSM265 Prophylaxis of Plasmodium Falciparum Malaria
A Phase 1 study testing DSM265, Sporozoites and Infective mosquito bite in people with Healthy, run by Medicines for Malaria Venture at 1 site in United States.
Trial summary
The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years. The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b). 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?
- DSM265, Sporozoites and Infective mosquito bite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
None listed.
Who cannot join
- Any history of malaria; any severe reactions to mosquito or insect bites; any history of anaphylaxis
- Plans to travel to malaria endemic region during the study period
- Previous participation in any malaria vaccine study or controlled human malaria infection study
- Participation in any other clinical study within 30 days of enrollment or plan to participate in another investigational vaccine/drug research during the study
- Breastfeeding or planning to become pregnant during the time of the study
- Positive Human Immunodeficiency Virus, Hepatitis B or C tests
Show all 20Show fewer
- Any confirmed/suspected immunosuppressive or immunodeficient state
- History of serious psychiatric condition that may affect participation in the study, or history of convulsions, seizures, or of severe head trauma
- Symptoms, physical signs or laboratory values suggestive of systemic disorders
- History of cancer (except basal cell carcinoma of the skin)
- History of arrhythmias or documented prolonged QTcF-interval (>450 msec) or 12-lead ECG demonstrating specific abnormalities
- Moderate risk or higher for cardiovascular event within 5 years (>10%)
- Positive family history in 1st or 2nd degree relative <50 years for cardiac disease, or history of, or known active cardiac disease
- history of: psoriasis or porphyria which may be exacerbated by chloroquine; splenectomy, or sickle cell anaemia or other red blood cell disorders; allergy or contra-indication to chloroquine or atovaquone-proguanil
- Treatment with an investigational drug within 28 days or 5 half-lives of study medication; use of any drugs or dietary supplements within 7 days or 5 half-lives prior to study medication. Herbal supplements must be discontinued at least 28 days prior to study medication. As an exception, acetaminophen or ibuprofen may be used as approved by the investigator
- Use of any prohibited medication
- Grapefruit or product containing grapefruit from28 days before study medication or throughout the study
- History of drug or alcohol abuse within 12 months prior to dosing, or laboratory evidence of abuse
- Current smoking of more than 10 cigarettes or equivalent per day
- Plan for major surgery between enrolment and study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center - Prevention Center
Seattle, Washington, 98109
About this study
Official title: Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum
The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.
The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
Read the detailed description
Cohort 1:
- Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
- Drug administration on Day -3
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in order to proceed to Cohorts 2a and 2b
Cohort 2a:
- Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
- Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo
Cohort 2b:
- Controlled human malaria infection on Day 0 (infected mosquito bite)
- Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo
- Conditions
- Healthy
- Being tested
- DSM265, Placebo, Sporozoites, Infective mosquito bite
- Keywords
- Controlled, Human, Malaria, Infection, Healthy, Volunteer
- Medical subject headings
- Malaria, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM265Drug
DSM265 400 mg single oral dose
PlaceboDrug
Placebo to match DSM265, single oral dose
SporozoitesBiological
Also called PfSPZ
Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
Infective mosquito biteBiological
Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Active DSM265 | Experimental | Not described Receives: Drug: DSM265; Biological: Sporozoites |
| Cohort 1 Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Biological: Sporozoites |
| Cohort 2a Active DSM265 | Experimental | Not described Receives: Drug: DSM265; Biological: Sporozoites |
| Cohort 2a Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Biological: Sporozoites |
| Cohort 2b Active DSM265 | Experimental | Not described Receives: Drug: DSM265; Biological: Infective mosquito bite |
| Cohort 2b Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Biological: Infective mosquito bite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with positive parasitemia
positive parasitemia detected by qRT-PCR
Measured: 28 days
Time interval between challenge and the first positive parasitemia
Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean [days]
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, United States Department of Defense, Center for Infectious Disease Research
- Responsible party
- Sponsor
- Investigators
- James G Kublin, MD/MPH, Principal investigator, Fred Hutchinson Cancer Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562872
- Sponsor's protocol ID
- MMV_DSM265_14_03
- Other IDs
- CDMRP-PR130402
- Status last verified
- Jan 2022
- First submitted
- 28 Sep 2015
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept, Single Center Study in Healthy Adult Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Prophylactic Activity of Single Dose DSM265 in a Controlled Human Malarial Infection Challenge Either by Direct Venous Inoculation of Plasmodium Falciparum Sporozoites or Mosquito-borne Plasmodium Falciparum
- ClinicalTrials.gov ID
- NCT02562872
- Acronym / sponsor ID
- MMV_DSM265_14_03
- Conditions
- Healthy
- Keywords
- Controlled, Human, Malaria, Infection, Healthy, Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, United States Department of Defense, Center for Infectious Disease Research
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single centre, randomised, placebo-controlled, double-blind study with DSM265 including up to two cohorts of healthy male and female volunteers aged 18 to 45 years.
The study will be conducted into two sequential parts (Cohort 1 and Cohorts 2a and 2b).
Detailed description
Cohort 1:
- Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
- Drug administration on Day -3
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo Clinical safety review of Cohort 1 in order to proceed to Cohorts 2a and 2b
Cohort 2a:
- Controlled human malaria infection on Day 0 (Direct Venous Inoculation of 3200 cryopreserved Plasmodium falciparum sporozoites)
- Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo
Cohort 2b:
- Controlled human malaria infection on Day 0 (infected mosquito bite)
- Drug administration on Day -X (to be defined following safety and pharmacokinetic data)
- 8 subjects: 6 DSM265 400 mg: 2 matching placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Active DSM265 | Experimental | Drug: DSM265, Biological: Sporozoites |
| Cohort 1 Placebo | Placebo comparator | Drug: Placebo, Biological: Sporozoites |
| Cohort 2a Active DSM265 | Experimental | Drug: DSM265, Biological: Sporozoites |
| Cohort 2a Placebo | Placebo comparator | Drug: Placebo, Biological: Sporozoites |
| Cohort 2b Active DSM265 | Experimental | Drug: DSM265, Biological: Infective mosquito bite |
| Cohort 2b Placebo | Placebo comparator | Drug: Placebo, Biological: Infective mosquito bite |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Any history of malaria; any severe reactions to mosquito or insect bites; any history of anaphylaxis
- Plans to travel to malaria endemic region during the study period
- Previous participation in any malaria vaccine study or controlled human malaria infection study
- Participation in any other clinical study within 30 days of enrollment or plan to participate in another investigational vaccine/drug research during the study
- Breastfeeding or planning to become pregnant during the time of the study
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 |
|---|---|---|
| DSM265DSM265 400 mg single oral dose | Drug | Cohort 1 Active DSM265, Cohort 2a Active DSM265, Cohort 2b Active DSM265 |
| PlaceboPlacebo to match DSM265, single oral dose | Drug | Cohort 1 Placebo, Cohort 2a Placebo, Cohort 2b Placebo |
| SporozoitesAlso: PfSPZDirect venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites | Biological | Cohort 1 Active DSM265, Cohort 1 Placebo, Cohort 2a Active DSM265, Cohort 2a Placebo |
| Infective mosquito biteFive single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum | Biological | Cohort 2b Active DSM265, Cohort 2b Placebo |
Primary outcome
Number of subjects with positive parasitemia
Time frame: 28 days
positive parasitemia detected by qRT-PCR
Time interval between challenge and the first positive parasitemia
Time frame: 28 days
Time from infection to peripheral parasitemia (qRT-PCR) in DSM265 / placebo treated subjects in each cohort given as a geometric mean [days]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- 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.
James G Kublin, MD/MPH principal investigator
Fred Hutchinson Cancer Research Centre
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, Sporozoites and Infective mosquito bite in people with Healthy, run by Medicines for Malaria Venture at 1 site in United States.
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 0 inclusion and 20 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 14 Jan 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with positive parasitemia (time frame: 28 days). 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?
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 14 Jan 2022.