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A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics

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Trial Profile

A Phase 1a, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Overlapping Single and Multiple Ascending Dose Escalation Study of WP1122 to Establish Maximum Tolerated Dose and Evaluate Pharmacokinetics

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Mar 2023

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At a glance

  • Drugs WP 1122 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors Moleculin Biotech

Most Recent Events

  • 19 Jan 2023 Status changed from active, no longer recruiting to completed.
  • 02 Nov 2022 Status changed from recruiting to active, no longer recruiting.
  • 14 Oct 2022 According to a Moleculin Biotech media release, In conjunction with the study safety review committee, the Company stopped the second MAD cohort when 2 subjects experienced adverse events. The Company has opened MAD cohort 2a, in which a minimum of 8 subjects will receive a daily dose of 48 mg/kg. The Company expects this to be the final dose escalation cohort in this trial, which is designed to establish a maximum tolerated dose.

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