Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2022-03-24

Brief Summary

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This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ATM001

Escalating dose levels of ATM001 administered as single dose in healthy subjects

Group Type EXPERIMENTAL

ATM001

Intervention Type BIOLOGICAL

monovalent anti-TNF-receptor 1 antibody format

ATM001 Placebo

Escalating dose levels of ATM001 Placebo administered as single dose in healthy subjects

Group Type PLACEBO_COMPARATOR

ATM001 Placebo

Intervention Type BIOLOGICAL

ATM001 Placebo

Interventions

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ATM001

monovalent anti-TNF-receptor 1 antibody format

Intervention Type BIOLOGICAL

ATM001 Placebo

Intervention Type BIOLOGICAL

Other Intervention Names

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Atrosimab

Eligibility Criteria

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Inclusion Criteria

* healthy male subjects
* body mass index 18-32 kg/m2
* normal physical examination, clinical laboratory values and ECG

Exclusion Criteria

* febrile or infectious illness at least 7 days prior to the first administration
* any active physical disease, acute or chronic
* history of alcohol or drug abuse
* history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes