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NCT04725175
Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers
Phase 1 trial testing PIPE-307 in Multiple Sclerosis in 70 participants. Completed in 1 September 2021.
1 September 2021
Quick facts
| Lead sponsor | Contineum Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 70 |
| Start date | 26 February 2021 |
| Primary completion | 1 September 2021 |
| Estimated completion | 1 September 2021 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- PIPE-307 — full drug profile →
- Placebo oral tablet — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Contineum Therapeutics — full company profile →
Who can join
Adults 18 to 55, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind study of PIPE-307 or placebo in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 24 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-307, enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Breaking the barriers to remyelination in multiple sclerosis.
Gharagozloo M, Bannon R, Calabresi PA. · · 2022 · cited 19× · PMID 35255453 · DOI 10.1016/j.coph.2022.102194 -
Targeting the muscarinic M1 receptor with a selective, brain-penetrant antagonist to promote remyelination in multiple sclerosis.
Poon MM, Lorrain KI, Stebbins KJ, Edu GC, et al · · 2024 · cited 17× · PMID 39083422 · DOI 10.1073/pnas.2407974121 -
Potential Role for Combined Subtype-Selective Targeting of M<sub>1</sub> and M<sub>3</sub> Muscarinic Receptors in Gastrointestinal and Liver Diseases.
Tolaymat M, Sundel MH, Alizadeh M, Xie G, et al · · 2021 · cited 12× · PMID 34803723 · DOI 10.3389/fphar.2021.786105 -
Remyelination in animal models of multiple sclerosis: finding the elusive grail of regeneration.
Packer D, Fresenko EE, Harrington EP. · · 2023 · cited 10× · PMID 37448959 · DOI 10.3389/fnmol.2023.1207007 -
Enhancing remyelination in multiple sclerosis via M1 muscarinic acetylcholine receptor.
Chen K, Park E, Abd-Elrahman KS. · · 2025 · cited 8× · PMID 40158341 · DOI 10.1016/j.molpha.2025.100027 -
The potential of repurposing clemastine to promote remyelination.
Yamazaki R, Ohno N. · · 2025 · cited 5× · PMID 40400770 · DOI 10.3389/fncel.2025.1582902
Verify or expand the search:
- PubMed search for NCT04725175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PIPE-307
Trials testing the same drug.
- NCT04941781 — PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy · Phase 1 · completed
Other recruiting trials for Multiple Sclerosis
Currently open trials in the same condition.
- NCT07507084 — The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Wal · NA · recruiting
- NCT07524231 — Evaluation of the Effects of Laughter Yoga · NA · recruiting
- NCT07489794 — URINARY INCONTINENCE AND PELVIC FLOOR MUSCLE ACTIVITY IN MULTIPLE SCLEROSIS · recruiting
- NCT07236684 — Identification of Factors Related to UI in Patients With MS and EMG Assessment of PFM Activity · recruiting
- NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting
Other Contineum Therapeutics trials
Trials by the same sponsor.
- NCT06810245 — Study of PIPE-791 for Subjects With Chronic Osteoarthritis Pain or Chronic Low Back Pain · Phase 1 · completed
- NCT06683612 — PET Study of PIPE-791 in Healthy Volunteers and Volunteers With PrMS and IPF · Phase 1 · completed
- NCT06083753 — Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis · Phase 2 · completed
- NCT05983939 — Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy · Phase 1 · completed
- NCT04941781 — PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04725175 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Contineum Therapeutics
- Last refreshed: 3 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04725175.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing