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NCT03923478
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
Phase 1 trial testing ABI-M201 in Ulcerative Colitis Chronic Mild in 15 participants. Terminated before completion.
20 January 2021
Quick facts
| Lead sponsor | Assembly Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 24 June 2019 |
| Primary completion | 20 January 2021 |
| Estimated completion | 20 January 2021 |
| Sites | 11 locations across Canada, United States |
Drugs / interventions tested
- ABI-M201 — full drug profile →
- Placebo
Conditions studied
- Ulcerative Colitis Chronic Mild — all drugs for Ulcerative Colitis Chronic Mild →
- Ulcerative Colitis Chronic Moderate — all drugs for Ulcerative Colitis Chronic Moderate →
Sponsor
Assembly Biosciences — full company profile →
Who can join
Adults 18 to 70, any sex, with Ulcerative Colitis Chronic Mild or Ulcerative Colitis Chronic Moderate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Designing bugs as drugs: exploiting the gut microbiome.
Lamousé-Smith E, Kelly D, De Cremoux I. · · 2021 · cited 6× · PMID 33264062 · DOI 10.1152/ajpgi.00381.2019
Verify or expand the search:
- PubMed search for NCT03923478
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ulcerative Colitis Chronic Mild
Currently open trials in the same condition.
- NCT05791487 — Combination of Diet and Oral Budesonide for Ulcerative Colitis · NA · recruiting
Other Assembly Biosciences trials
Trials by the same sponsor.
- NCT06740474 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants · Phase 1 · completed
- NCT06698575 — A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropos · Phase 1 · completed
- NCT06384131 — A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B · Phase 1 · completed
- NCT06385327 — A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participa · Phase 1 · completed
- NCT05569941 — A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects · 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 NCT03923478 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Assembly Biosciences
- Last refreshed: 19 March 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/NCT03923478.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing