ClinicalTrialsFinder
CompletedPhase 1ACTRN12617000711314

Clinical trial investigating if anti-malaria treatment DSM265 causes an allergic reaction.

Allergic potential of DSM265 in human subjects: a Skin Prick Test Study .

Sponsor

Medicines for Malaria Venture (MMV) - Non Profit Product Development Partnership

Enrollment

11 participants

Start Date

May 16, 2017

Study Type

Interventional

Conditions

Tolerability of Anti-Malaria Vaccine

Summary

This is a clinical research study investigating the allergic potential of the experimental anti-malarial drug DSM265. Following the occurrence of cutaneous rash in one healthy subject (hereafter, subject R107) involved in a clinical investigation of the antimalarial potential of DSM265 (QP15C11/P2142), the study sponsor intends to perform cutaneous testing with DSM265. This new study has 3 parts. In Part 1, skin prick testing with various concentrations of DSM265 will be carried out in 10 healthy volunteers, to determine a non-irritant concentration for subsequent testing. In Part 2, subject R107 will be skin prick tested for DSM265 allergy, as well as for allergy to polysorbate 80, an excipient used in the preparation and in many commercially available drugs. Part 3 of the study will proceed if subject R107 skin prick testing in Part 2 is negative or inconclusive: subject R107 will be administered DSM265 p.o. and assessed for allergic symptoms.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria8

  • Single study split into 3 parts. Healthy Volunteers for Part 1 and known participant R107 (from previous study) for part 2 and 3
  • PART 1
  • Healthy male or female 18-55 y.o
  • No clinically significant abnormality on vital signs, safety laboratory tests and ECGs within normal range at screening.
  • PART 2 - known participant to be screened to ensure participant safety:
  • No clinically significant abnormality on vital signs, safety laboratory tests and ECGs within normal range at screening.
  • PART 3 - known participant to be screened to ensure participant safety:
  • No clinically significant abnormality on vital signs, safety laboratory tests and ECGs within normal range at screening and admission.

Exclusion Criteria22

  • PART 1
  • Diffuse dermatological conditions (requirement for healthy skin for testing)
  • Severe dermatographism
  • Severe or uncontrolled asthma
  • Infections of the skin at the test area
  • Personal history of allergy (including seasonal allergies/allergic rhinitis)
  • Acute inflammatory status (i.e. fever 38.0 degrees C and/or CRP 20 mg/L) or with concurrent illness (i.e. viral, bacterial)
  • Breast-feeding mothers and pregnant females (positive pregnancy test)
  • Treatments that may interfere with the interpretation of the SPT (listed in appendix of protocol, as well as the following class of drugs : beta-blockers, ACE (Angiotensin-converting-enzyme) inhibitors, calcineurin inhibitors, systemic corticosteroids, or topical corticosteroids used at the tested skin area. The minimum washout period for these drugs should be 2 weeks or 5 half-lives whichever is the longer.
  • PART 2
  • Diffuse dermatological conditions (requirement for healthy skin for testing)
  • Severe dermatographism
  • Severe or uncontrolled asthma
  • Infections of the skin at the test area
  • Acute inflammatory status (i.e. fever 38.0 degrees C and/or CRP 20 mg/L) or with concurrent illness (i.e. viral, bacterial)
  • Breast-feeding or positive pregnancy test
  • Treatments that may interfere with the interpretation of the SPT as well as the following class of drugs : beta-blockers, ACE (Angiotensin-converting-enzyme) inhibitors, calcineurin inhibitors, systemic corticosteroids, or topical corticosteroids used at the tested skin area. The minimum washout period for these drugs should be 2 weeks or 5 half-lives whichever is the longer.
  • PART 3
  • Severe or uncontrolled asthma
  • Acute inflammatory status (i.e. fever 38.0 degrees C and/or CRP 20 mg/L at screening) or with concurrent illness (i.e. viral, bacterial)
  • Breast-feeding or positive pregnancy test
  • Treatments that may interfere with the interpretation of the Drug Provocation Test as well as the following class of drugs : beta-blockers, ACE (Angiotensin-converting-enzyme) inhibitors, calcineurin inhibitors, systemic corticosteroids, or topical corticosteroids. The minimum washout period for these drugs should be 2 weeks or 5 half-lives whichever is the longer.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Single study split into 3 parts. Data from part 1 will be used to determine dilution concentrations of DSM265 for Part 2 and safety data from Part 2 will determine proceeding to Part 3. Healthy volu

Single study split into 3 parts. Data from part 1 will be used to determine dilution concentrations of DSM265 for Part 2 and safety data from Part 2 will determine proceeding to Part 3. Healthy volunteers involved in Part 1 only . A single participant who was previously experienced a experienced a cutaneous allergic reaction to DSM265 will participate in Parts 2 and 3. Part 1: Skin Prick Test with: -4 incremental concentrations (1:1000, 1:100, 1: 10 and 1:1) of DSM265 solutions - Positive control (histamine dihydrochloride) -Negative control (glycerine-saline). All participants will receive all four doses of DSM265. Safety Assessments (clinical haematology and biochemistry blood tests, viral serology (HIV, Hep B, Hep C) vitals signs, ECG, urinalysis) Urine Drug screening Pregnancy Testing Part 2: Skin Prick Test: -3 incremental concentrations of the non-irritant dose of DSM265 determined from Part 1 (1:1, 1:10, 1:100) -Positive control (histamine dihydrochloride) -Negative control (glycerine-saline) -Reference concentration (1:1000) of Polysorbate 80 Safety Assessments (clinical haematology and biochemistry blood tests, viral serology (HIV, Hep B, Hep C) vitals signs, ECG, urinalysis) Urine Drug screening Pregnancy Testing Part 3: Oral dose of DSM265 of up to 400mg . The patient will be given an initial dose equivalent to 1:10 (40mg) of the previous dose linked to the cutaneous reaction in study QP15C11. If there has been no development of signs or symptoms of a reaction after 2 hours of the first dose, a second dose equivalent to 9:10 (360mg) of DSM 265 will be given and the patient observed for a further 3 hours. Safety Assessments (clinical haematology and biochemistry blood tests, viral serology (HIV, Hep B, Hep C) vitals signs, ECG, urinalysis) Urine Drug screening Pregnancy Testing skin biopsy (if required)

Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12617000711314