PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
← catalyst calendarNCT06961565 · readout ≤ 406 d
Sponsored by Pasithea Therapeutics Corp. (industry) · KTTA — their whole pipeline →. With Novotech (Australia) Pty Limited.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
56estimated
Sites
5
Countries
Australia, South Korea, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-05-30 | actual | When the study began enrolling |
| Primary completion | Sep 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- NF1 Mutation
- Neurofibroma Plexiform
- Neurofibroma, Plexiform
- Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)
- Neurofibromatosis Type 1 (NF1)
Intervention
- Drug: PAS-004 Tablets
Primary outcomes
what the primary-completion date above is the date OFPart A: To evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle
measured Part A from enrollment (Day 1) through Day 28 (completion of Cycle 1)
Part B: To evaluate the safety and tolerability of PAS-004 when administered for six 28-day treatment cycle
measured Part B from enrollment (Day 1) through Day 168 (completion of Cycle 6) [each cycle is 28 days]
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