NCT05454410 - Study of Efficacy, Safety, Tolerability and Pharmacokinetics of MIJ821 in Participants With Treatment- Resistant Depression (TRD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 13, 2023

Primary Completion Date

November 28, 2023

Study Completion Date

November 28, 2023

Conditions

Treatment-Resistant Depression

Interventions

DRUG

MIJ821 Subcutaneous Injection 1 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

DRUG

MIJ821 Subcutaneous Injection 4 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

DRUG

MIJ821 Subcutaneous Injection 10 mg

MIJ821 supplied in vials as a powder for solution for injection, reconstituted and administered as a single SC injection on Day 1.

DRUG

Placebo Subcutaneous Injection

0.9% sodium chloride solution administered as a single SC injection on Day 1.

Trial Locations (16)

31008

Novartis Investigative Site, Pamplona

33334

Research Centers of America LLC, Oakland Park

33629

Interventional Psychiatry Tampa Bay, Tampa

35294

25Uni of Alabama at Birmingham, Birmingham

41013

Novartis Investigative Site, Seville

236-0004

Novartis Investigative Site, Yokohama

187-8551

Novartis Investigative Site, Kodaira

181-8611

Novartis Investigative Site, Mitaka

15 276

Novartis Investigative Site, Bialystok

80 952

Novartis Investigative Site, Gdansk

86-100

Novartis Investigative Site, Swiecie North West

08208

Novartis Investigative Site, Sabadell

08830

Novartis Investigative Site, Sant Boi de Llobregat

08035

Novartis Investigative Site, Barcelona

08025

Novartis Investigative Site, Barcelona

08041

Novartis Investigative Site, Barcelona