Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-08-25

Brief Summary

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This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

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Detailed Description

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This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Matched placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

MOTREM 1

nangibotide dose 1

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 2

Nangibotide dose 2

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 3

Nangibotide dose 3

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 4

Nangibotide dose 4

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 5

Nangibotide dose 5

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 6

Nangibotide dose 6

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 7

Nangibotide dose 7

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

MOTREM 8

Nangibotide dose 8

Group Type EXPERIMENTAL

nangibotide

Intervention Type DRUG

Continous i.v. infusion

Interventions

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nangibotide

Continous i.v. infusion

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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LR12 MOTREM matched placebo

Eligibility Criteria

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Inclusion Criteria

* healthy male
* ≥18 to ≤45 years old
* Body mass index (BMI) between 18-30 kg/m² inclusive
* Written informed consent to participate.

Exclusion Criteria

* Any clinically relevant acute or chronic diseases
* Any history of drug or alcohol abuse
* Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes