NCT03507738 is a Phase 1 clinical trial of MT-5625 low dose in Healthy, sponsored by Tanabe Pharma Corporation.

Who is sponsoring NCT03507738?

NCT03507738 is sponsored by Tanabe Pharma Corporation.

What drugs are being tested in NCT03507738?

Interventions in NCT03507738: MT-5625 low dose, MT-5625 middle dose, MT-5625 high dose, Rotarix, Placebo.

Is NCT03507738 still recruiting?

NCT03507738 is currently completed. Last updated 6 August 2019.

Last reviewed 2019-08-06 · How we verify

NCT03507738

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants

Completed Phase 1 Last updated 6 August 2019

What this trial tests

Phase 1 trial testing MT-5625 low dose in Healthy in 110 participants. Completed in 28 June 2019.

Timeline

3 July 2018

Primary endpoint
28 June 2019

28 June 2019

Quick facts

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	110
Start date	3 July 2018
Primary completion	28 June 2019
Estimated completion	28 June 2019
Sites	2 locations across South Africa, Australia

Drugs / interventions tested

MT-5625 low dose — full drug profile →
MT-5625 middle dose — full drug profile →
MT-5625 high dose — full drug profile →
Rotarix — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Tanabe Pharma Corporation — full company profile →

Who can join

Adults 6 Weeks to 35, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Update on rotavirus vaccine underperformance in low- to middle-income countries and next-generation vaccines.
Lee B. · · 2021 · cited 49× · PMID 33327868 · DOI 10.1080/21645515.2020.1844525
Plant-Derived Human Vaccines: Recent Developments.
Stander J, Mbewana S, Meyers AE. · · 2022 · cited 25× · PMID 35821564 · DOI 10.1007/s40259-022-00544-8
Safety and immunogenicity of a plant-derived rotavirus-like particle vaccine in adults, toddlers and infants.
Kurokawa N, Robinson MK, Bernard C, Kawaguchi Y, et al · · 2021 · cited 22× · PMID 34454786 · DOI 10.1016/j.vaccine.2021.08.052
Immunogenicity and efficacy of recombinant subunit SARS-CoV-2 vaccine candidate in the Syrian hamster model.
Shanmugaraj B, Khorattanakulchai N, Paungpin W, Akkhawattanangkul Y, et al · · 2023 · cited 7× · PMID 36533163 · DOI 10.1016/j.btre.2022.e00779
Tobacco-Based Vaccines, Hopes, and Concerns: A Systematic Review.
Mathew M, Thomas J. · · 2023 · cited 5× · PMID 36528727 · DOI 10.1007/s12033-022-00627-5
Antigen Delivery Systems: Past, Present, and Future.
Ko HJ, Kim YJ. · · 2023 · cited 4× · PMID 37072288 · DOI 10.4062/biomolther.2023.006

Verify or expand the search:

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Other Tanabe Pharma Corporation trials

Trials by the same sponsor.

NCT06994286 — The Purpose of This Study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects · Phase 1 · completed
NCT06482346 — Clinical Pharmacology Study of MT-3534 in Healthy Adult Male Volunteers · Phase 1 · completed
NCT06196905 — An Exploratory Study of MT-2990 in Patients With AAV · Phase 1 · completed
NCT05568615 — Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS · Phase 3 · completed
NCT05396235 — A Clinical Pharmacology Study of MT-3921 in Healthy Adult Males · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03507738 (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 Tanabe Pharma Corporation
Last refreshed: 6 August 2019

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/NCT03507738.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing