Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects
NCT03463044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2025-02-10
Summary
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
Conditions
- Healthy Subjects
Interventions
- DRUG
-
nangibotide
Continous i.v. infusion
- DRUG
-
Placebo
Sponsors & Collaborators
-
Richmond Pharmacology Limited
collaborator INDUSTRY -
Inotrem
lead INDUSTRY
Principal Investigators
-
Valérie Cuvier · Inotrem
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-04-01
- Primary Completion
- 2016-08-25
- Completion
- 2016-08-25
Countries
- United Kingdom
Study Locations
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