Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-12

Study Completion Date

2027-03-09

Brief Summary

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The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) of subcutaneously administered M5542.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M5542

Group Type EXPERIMENTAL

M5542

Intervention Type BIOLOGICAL

Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

Interventions

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M5542

Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.

Intervention Type BIOLOGICAL

Placebo

Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants are overtly healthy, as determined by medical evaluation, by 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 study evaluation, procedures, or completion at Screening and Day -1
* Participants have a body weight within the range 50 to 100 kilograms (kg) (inclusive) and body mass index (BMI) within the range 18 to 30.0 kilograms per square meter kg/m\^2 (inclusive) at Screening

Exclusion Criteria

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric and other diseases or disorders, and epilepsy, as determined by medical evaluation at Screening and Day -1
* Any condition, including findings in the laboratory tests or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation at Screening and on Day -1
* History of any malignancy
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
* Immunization with any vaccine 42 days prior to dosing on Day 1 or planned within 3 months after the last administration of study intervention

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes