NCT05103878: A Phase 1, Single-Ascending-Dose Study of BT051 in Healthy Subjects

Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of single ascending doses of BT051 in healthy male or female volunteers aged 18 to \<50 years. A total of 50 subjects will be randomized to receive a single oral dose of BT051 or matching placebo in a ratio of 4 active:1 placebo in 5 ascending dose cohorts (10 subjects per cohort) at active dose levels of 100mg, 300mg, 700mg, 1500mg or 3500mg. The study Safety Review Committee (SRC) will evaluate if any dose-limiting adverse events (AEs) occurred in a cohort through Day 3, as well as review cumulative safety data for all previous cohorts and any available pharmacokinetic (PK) data before proceeding to dosing in the next cohort.

Timeline

Start: 2020-06-24
Primary completion: 2020-11-13
Completion: 2020-11-13

Publications

Cheifetz AS, Allegretti JR, Quintas M, Dixit B, Farquhar R, Miller BW, Murphy CK, Hershberger E, Ghahramani P, Stevens AC. Small-Molecule Neutrophil Modulator ADS051 is Safe and Well-Tolerated in a Phase 1 Single Ascending Dose Study. Am J Gastroenterol. 2024 Nov 26;120(7):1585-1592. doi: 10.14309/ajg.0000000000003237.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PEGMISPOTIDE	Small molecule	100 mg	Oral
Subject	PEGMISPOTIDE	Small molecule	300 mg	Oral
Subject	PEGMISPOTIDE	Small molecule	700 mg	Oral
Subject	PEGMISPOTIDE	Small molecule	1500 mg	Oral
Subject	PEGMISPOTIDE	Small molecule	3500 mg	Oral

Indications

No indication recorded.