Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects
Lead Sponsor:
Inotrem
Collaborating Sponsors:
Richmond Pharmacology Limited
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 hea...
Detailed Description
This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans
Eligibility Criteria
Inclusion
- healthy male
- ≥18 to ≤45 years old
- Body mass index (BMI) between 18-30 kg/m² inclusive
- Written informed consent to participate.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03463044
Start Date
April 1 2016
End Date
August 25 2016
Last Update
February 10 2025
Active Locations (1)
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1
Richmond Pharmacology Ltd.
Croydon, United Kingdom