NCT03492385

Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI2452 (PB2452) With and Without Ticagrelor Pretreatment in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: SFJ Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single ascending dose, sequential group study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment when administered to healthy male and female subjects. Up to 6 dose levels will be evaluated. This study will have up to 10 cohorts and up to a total of approximately 76 subjects with either 4 or 8 healthy young subjects in Cohorts 1 through 9 or approximately 16 older subjects in Cohort 10. The starting dose of PB2452 will be 100 mg and the planned doses for subsequent cohorts are 300, 1000, 3000, 9000, and 18000 mg.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PB2452 Infusion	30 minute - 12 hour infusion
DRUG	Placebo - Sodium Chloride	30 minute - 12 hour infusion
DRUG	Ticagrelor Oral Tablet - Pre-Treatment	Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo
DRUG	Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment	Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo

Timeline

• Start date: 2018-04-03
• Primary completion: 2018-09-18
• Completion: 2018-09-18
• First posted: 2018-04-10
• Last updated: 2024-11-04
• Results posted: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study