Status:
COMPLETED
First-in-Human Trial of Single Ascending Dose, Multiple Ascending Dose and Malaria Challenge Model in Healthy Participants
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study was to investigate the safety and tolerability of M5717 and to characterize the Pharmacokinetics (PK) /Pharmacodynamic relationship between M5717 PK and parasite clea...
Eligibility Criteria
Inclusion
- Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m\^2) and 29.9 kg/m\^2.
- Healthy as assessed by the Investigator with 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 trial evaluation, procedures, or completion.
- Other protocol defined inclusion criteria could apply.
Exclusion
- Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
- Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
- Participants who have any history of malaria.
- Participants who have participated in a previous malaria vaccine trial.
- Participants who have participated in a previous human malaria challenge trial.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03261401
Start Date
September 15 2017
End Date
June 14 2019
Last Update
October 16 2023
Active Locations (1)
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1
Q-Pharm Pty Ltd
Brisbane, Australia