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A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD

NCT05414422 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-06-04

Study results available
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Summary

This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3 phases:screening (up to 2 weeks \[Day -15 to Day -2\]), In-Clinic Treatment (Day -1 to Day 2; including double-blind treatment \[Day 1\]), and post-treatment follow-up (7 and 14 days after infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a blinded manner.

Conditions

Interventions

DRUG

PCN-101

Concentrate for solution for infusion

DRUG

Placebo

Concentrate for solution for infusion

Sponsors & Collaborators

  • Precision For Medicine

    collaborator INDUSTRY

  • IQVIA Biotech

    collaborator INDUSTRY

  • Perception Neuroscience

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Perception Neuroscience

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-11-10
Completion
2022-11-10
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414422 on ClinicalTrials.gov