drugset / Trial / NCT05414422
A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Phase 2
Completed
102 enrolled
Perception Neuroscience
IQVIA Biotech · collabPrecision For Medicine · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2022-11-10
- Completion
- 2022-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HR071603 | Unknown | 30 mg | Intravenous |
| Subject | HR071603 | Unknown | 60 mg | Intravenous |
Indications
No indication recorded.