A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects

Phase 1 Completed 78 enrolled Galecto Biotech AB

RandomizedSequentialQuadruple-blindOther

Summary

This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult subjects with indication of suspected Nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Timeline

Start: 2019-01-14
Primary completion: 2019-06-25
Completion: 2019-06-25

Publications

Aslanis V, Slack RJ, MacKinnon AC, McClinton C, Tantawi S, Gravelle L, Nilsson UJ, Leffler H, Brooks A, Khindri SK, Marshall RP, Pedersen A, Schambye H, Zetterberg F. Safety and pharmacokinetics of GB1211, an oral galectin-3 inhibitor: a single- and multiple-dose first-in-human study in healthy participants. Cancer Chemother Pharmacol. 2023 Mar;91(3):267-280. doi: 10.1007/s00280-023-04513-y. Epub 2023 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selvigaltin	Small molecule	5 mg	Oral
Subject	Selvigaltin	Small molecule	20 mg	Oral
Subject	Selvigaltin	Small molecule	50 mg	Oral
Subject	Selvigaltin	Small molecule	100 mg	Oral
Subject	Selvigaltin	Small molecule	200 mg	Oral
Subject	Selvigaltin	Small molecule	400 mg	Oral

Indications

No indication recorded.