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A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects

NCT05857215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-05-12

No results posted yet for this study

Summary

This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)

Conditions

  • Inflammatory Disease

Interventions

DRUG

amilo-5MER

amilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine).

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • John Posner, PhD, FRCP · Pharmaceutical medicine consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857215 on ClinicalTrials.gov