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Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects

NCT04691115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2024-08-02

Study results available
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Summary

This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM1476 in healthy subjects.

Conditions

  • Safety
  • Tolerability

Interventions

DRUG

AM1476

AM1476 Capsules

DRUG

Placebo

Placebo Capsules

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • AnaMar AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04691115 on ClinicalTrials.gov