NCT07370155

Study Evaluating Safety & Tolerability of Migaldendranib in Healthy Volunteers

A Phase 1, Open-Label, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Migaldendranib (MGB) in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ashvattha Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, open-label, multiple-dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MGB administered following weekly subcutaneous dosing in healthy adult volunteers. Up to 36 participants will be enrolled at a single site in Australia. The study includes a screening period of up to 27 days, an 18-day treatment period, and follow-up visits on Days 22 and 29. Participants will be enrolled into up to six sequential dose-escalation cohorts (up to six participants per cohort) using a sentinel dosing approach. Dosing includes weekly subcutaneous administration of MGB at escalating doses.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-29
• Primary completion: 2026-05-13
• Completion: 2026-06-10
• First posted: 2026-01-27
• Last updated: 2026-02-04