NCT07364513

Phase 1b Safety Study of IMSB301 in Type 1 Interferonopathies

A Phase 1b Open-Label Study of IMSB301 in Subjects With a Type 1 Interferonopathy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: ImmuneSensor Therapeutics Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Open-Label Study (Phase Ib) of Type 1 Interferonopathy patients receiving IMSB301 monotherapy.

Detailed description

This is an open-label, Phase Ib study designed to evaluate the safety of IMSB301 monotherapy in Type 1 Interferonopathy patients. The dose of IMSB301 will be based on the recommended Phase Ib dose from Phase Ia. The following methodology applies to all patients (unless otherwise indicated): * On Day 1 the first dose of IMSB301 will be administered. * Subjects will be observed for a minimum period of 6 hours after the dose, and unless acute safety or tolerability issues emerge, they will be discharged and dispensed with study drug sufficient to last until the next visit (Day 8). * The morning and evening doses will be separated by \~12 hours, and administered at approximately the same time daily. * Subjects will be treated as out-patients and will return to the clinic at least once weekly. Subsequent study site visits will be morning of Days 8, 15, 22 and 29. * The subject will have three further visits during the 28-day follow-up period, on Days 36, 43 and 57 (EOS). * Continued treatment with IMSB301 beyond Day 28 may be considered on a case-by-case basis for subjects benefiting from treatment in the opinion of the Investigator, as outlined in Appendix B.

Conditions

• Type 1 Interferonopathies

Interventions

Type	Name	Description
DRUG	IMSB301	Twice daily administration for 28 days. Subjects will be treated as out-patient and will return to the clinic at least once weekly on Days 8, 15, 22 and 29. Continued treatment beyond Day 28 may be considered on a case-by-case basis for subjects benefiting from treatment.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-07-30
• Completion: 2026-07-30
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Australia