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Clinical Trials/NL-OMON48517
NL-OMON48517CompletedNot Applicable

A FIRST-IN-HUMAN, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS (INCLUDING FOOD EFFECT) OF IMB­1018972 IN HEALTHY SUBJECTS - IMB1018972 SAD and MAD study

Imbria Pharmaceuticals, Inc.0 sites128 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
128
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Gender: male or female.
  • •2. Age:18 to 65 years, inclusive, at screening.
  • •3. Body mass index : 18.0 to 32.0 kg/m2.
  • •4. Status: healthy subjects.
  • •5. At screening, females can be of childbearing potential (but not pregnant or
  • •lactating), or of nonchildbearing potential (either surgically sterilized or
  • •physiologically incapable of becoming pregnant, or at least 1 year
  • •postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy
  • •will be confirmed for all females by a serum pregnancy test conducted at
  • •screening and each admission.

Exclusion Criteria

  • •1. Previous participation in the current study.
  • •2. Employee of PRA or the Sponsor.
  • •3. History of relevant drug and/or food allergies.
  • •4. Using tobacco products within 3 months prior to (the first) drug
  • •administration.
  • •5. History of alcohol abuse or drug addiction (including soft drugs like
  • •cannabis products).

Investigators

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