Autopsy report · NCT05162131

Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 With and Without Ticagrelor Pretreatment in Chinese Healthy Volunteers

“After recruitment of Cohorts 1-4 was completed, Sponsor decided to terminate study, initially due to COVID and then considering that PK data from the dose planned to be tested in Cohort 5 (18000 mg) would be available from the ongoing Phase 3 study.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year before it stopped.
• 34 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

SFJ Pharmaceuticals, Inc.

Sponsor type

Industry

Conditions

Healthy

Interventions

Bentracimab (PB2452) 100 mg or Placebo; Bentracimab (PB2452) 300 mg or Placebo; Bentracimab (PB2452) 1000 mg or Placebo; Bentracimab (PB2452) 1000 mg or Placebo (With Ticagrelor Pre-Treatment); Bentracimab (PB2452) 3000 mg or Placebo (With Ticagrelor Pre-Treatment); Bentracimab (PB2452) 9000 mg or Placebo (With Ticagrelor Pre-Treatment)

Participants

34

Sites

1

Countries

China

Trials that died the same way

• An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
  “As of 31 JAN 2018, the study was terminated by the sponsor due to PK variability.” (76% match in meaning)
• A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
  “The sponsor decided to terminate the study early, due to recruitment challenges for Part II and, based on the totality of data generated with a low likelihood of achieving the targeted efficacy, to open Part III.” (70% match in meaning)
• Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
  “It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.” (68% match in meaning)
• MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
  “The Sponsor is terminating the study because the primary objective was achieved after 5 of the 6 subjects were assessed in the final cohort.” (68% match in meaning)
• Reparixin in COVID-19 Pneumonia - Efficacy and Safety
  “The sponsor has decided to start with a separate protocol for phase 3 and therefore this study was terminated with only phase 2.” (67% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.