NCT03179878 (SYNB1020CP001) is a Phase 1 clinical trial of SYNB1020 in Healthy Volunteer, sponsored by Synlogic.

Who is sponsoring NCT03179878?

NCT03179878 is sponsored by Synlogic.

What drugs are being tested in NCT03179878?

Interventions in NCT03179878: Placebo, SYNB1020.

What condition does NCT03179878 study?

NCT03179878 studies Healthy Volunteer, Urea Cycle Disorder.

Is NCT03179878 still recruiting?

NCT03179878 is currently completed. Last updated 12 May 2021.

Last reviewed 2021-05-12 · How we verify

NCT03179878: SYNB1020CP001

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

Safety and Tolerability of SYNB1020-CP-001

Completed Phase 1 Last updated 12 May 2021

What this trial tests

Phase 1 trial testing Placebo in Healthy Volunteer in 52 participants. Completed in 11 April 2018.

Timeline

16 June 2017

Primary endpoint
2 November 2017

11 April 2018

Quick facts

Lead sponsor	Synlogic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	52
Start date	16 June 2017
Primary completion	2 November 2017
Estimated completion	11 April 2018
Sites	1 location across United States

Drugs / interventions tested

Placebo
SYNB1020 — full drug profile →

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →
Urea Cycle Disorder — all drugs for Urea Cycle Disorder →

Sponsor

Synlogic — full company profile →

Who can join

Adults 18 to 64, any sex, with Healthy Volunteer or Urea Cycle Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase 1, First-in-human, Oral Single and Multiple Dose-Escalation, Randomized, Double-blinded, Placebo-controlled Study of SYNB1020 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Dosing, and Pharmacodynamics

Publications & conference data

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

Theranostic cells: emerging clinical applications of synthetic biology.
McNerney MP, Doiron KE, Ng TL, Chang TZ, et al · · 2021 · cited 78× · PMID 34234299 · DOI 10.1038/s41576-021-00383-3
Engineered probiotics.
Ma J, Lyu Y, Liu X, Jia X, et al · · 2022 · cited 72× · PMID 35477497 · DOI 10.1186/s12934-022-01799-0
Microbial therapeutics: New opportunities for drug delivery.
Jimenez M, Langer R, Traverso G. · · 2019 · cited 43× · PMID 31028093 · DOI 10.1084/jem.20190609
Clinical translation of microbe-based therapies: Current clinical landscape and preclinical outlook.
Vargason AM, Anselmo AC. · · 2018 · cited 36× · PMID 30065967 · DOI 10.1002/btm2.10093
Microbiome engineering: engineered live biotherapeutic products for treating human disease.
Rutter JW, Dekker L, Owen KA, Barnes CP. · · 2022 · cited 34× · PMID 36185459 · DOI 10.3389/fbioe.2022.1000873
Genetically Engineered Microorganisms and Their Impact on Human Health.
Mahdizade Ari M, Dadgar L, Elahi Z, Ghanavati R, et al · · 2024 · cited 17× · PMID 38495751 · DOI 10.1155/2024/6638269
Engineering bacteria to modulate host metabolism.
Ciocan D, Elinav E. · · 2023 · cited 11× · PMID 37222395 · DOI 10.1111/apha.14001
Precision microbial regulation: Strategies for modulating GIT microbiota for host health.
Zhong P, Li Q, Zhang Y, Guo C, et al · · 2025 · PMID 41675700 · DOI 10.1002/imo2.54

Verify or expand the search:

Other trials of SYNB1020

Trials testing the same drug.

NCT03447730 — Safety, Tolerability and Pharmacodynamics of SYNB1020 · Phase 1, PHASE2 · terminated

Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

NCT06274749 — Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Mask · NA · recruiting
NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
NCT06845176 — Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery · NA · recruiting
NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
NCT07220122 — Impact of Exogenous Ketones on Breathing in Healthy Volunteers · EARLY_PHASE1 · recruiting

Other Synlogic trials

Trials by the same sponsor.

NCT05764239 — Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) · Phase 3 · terminated
NCT05462132 — Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers · Phase 1 · completed
NCT05377112 — Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bow · EARLY_PHASE1 · completed
NCT04984525 — Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers · Phase 1 · completed
NCT04629170 — Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria · 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 NCT03179878 (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 Synlogic
Last refreshed: 12 May 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/NCT03179878.

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