Study S003376

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase Ia Study in Chinese Healthy Adult Subjects to Investigate the Safety, Tolerability and Pharmacokinetic of TG103

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: NCT03990090
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 32
Start: 2019-07-29
Primary completion: 2020-11-11
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions: Healthy
Interventions: DRUG:TG103; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 28]

Linked records (1)

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
R0030139	Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. Jin J, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences	2023	Randomized trial	PMID 37062422 DOI	cites ClinicalTrials.gov:NCT03990090; registry reference DERIVED:37062422