Study S001846

A Phase 1, Single- and Multiple-Dose, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of NLY01 in Healthy Subjects

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT03672604
Acronym: NLY01-H1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 96
Start: 2018-09-19
Primary completion: 2019-07-30
Lead sponsor: Neuraly, Inc.
Conditions: Safety and Tolerability in Healthy Volunteers
Interventions: DRUG:NLY01
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Treatment-Related Adverse Events [Day 1 through Day 29 (Part A) or Day 57 (Part B)]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013400	Emerging PEGylated non-biologic drugs. Park EJ, Expert opinion on emerging drugs	2019	Narrative review	PMID 30957581 DOI	cites ClinicalTrials.gov:NCT03672604; registry reference DERIVED:30957581
R0030072	Block of A1 astrocyte conversion by microglia is neuroprotective in models of Parkinson's disease. Yun SP, Nature medicine	2018	Preclinical	PMID 29892066 DOI	registry reference BACKGROUND:29892066