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Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)

NCT07029412 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-17

No results posted yet for this study

Summary

The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH

Conditions

Interventions

DRUG

MBX 1416 (INN imapextide)

A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.

Sponsors & Collaborators

  • MBX Biosciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2025-12-22
Completion
2026-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07029412 on ClinicalTrials.gov