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A Study to Assess the Safety of MEB-1170 in Healthy Subjects

NCT05748119 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-02-28

No results posted yet for this study

Summary

Primary Objective: To determine the safety and tolerability of single and multiple ascending oral doses of MEB-1170 in healthy subjects.

Secondary Objectives:

1. To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite, M373, in healthy subjects.
2. To determine the effect of food on the pharmacokinetic (PK) profile of a single oral dose of MEB-1170 in healthy subjects.
3. To assess the pharmacodynamic (PD) response following single and multiple oral doses of MEB-1170

Conditions

Interventions

DRUG

MEB-1170

Depending on the dosage, either 20 mg, 40 mg capsules, or a combination of both

DRUG

Placebo

Equivalent number and size of capsules containing placebo

Sponsors & Collaborators

  • Mebias Discovery, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-10-01
Completion
2023-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT05748119 on ClinicalTrials.gov