Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: M5049; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03676322

2018-001256-35 (EudraCT Number)

MS200569_0001

Details and patient eligibility

About

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.

Enrollment: 96 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight between 50 to 100 kilogram (kg)
• Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
• History of splenectomy
• History of epilepsy, other neurological disorders, or neuropsychiatric conditions
• Other protocol defined exclusion criteria could apply

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 5 patient groups, including a placebo group

Part A: M5049

Experimental group

Treatment:

Drug: M5049

Part A: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Part B: M5049

Experimental group

Treatment:

Drug: M5049

Part B: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Part C: M5049

Experimental group

Treatment:

Drug: M5049