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Study Evaluating Safety & Tolerability of Migaldendranib in Healthy Volunteers

NCT07370155 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-08-27

No results posted yet for this study

Summary

This is a Phase 1, open-label, multiple-dose study to evaluate the safety, tolerability, and PK of MGB after weekly subQ MGB administration in up to 36 healthy volunteers at 1 site in Australia.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MGB 200 mg

Participants receive weekly subcutaneous administration of MGB

DRUG

MGB 400 mg

Participants receive an intermediate dose of MGB administered subcutaneously once weekly

DRUG

MGB 600 mg

Participants receive the highest planned dose of MGB administered subcutaneously

Sponsors & Collaborators

  • Ashvattha Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-01-29
Primary Completion
2026-03-05
Completion
2026-10-10

Countries

  • Australia

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 NCT07370155 on ClinicalTrials.gov