Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07633288
PHASE2

A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses

Sponsor: SynAct Pharma Aps

View on ClinicalTrials.gov

Summary

A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.

Official title: A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-05-01

Completion Date

2027-08-01

Last Updated

2026-07-28

Healthy Volunteers

No

Interventions

DRUG

AP1189, 100 mg

14 days of daily treatment of oral AP1189 100 mg as add-on to Standard of Care treatment

DRUG

Placebo

14 days of daily treatment of AP1189 matching placebo as add-on to Standard of Care treatment

Locations (11)

University Clinical Hospital Mostar, Clinic for Infectious Diseases

Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina

University Clinical Center Republic of Srpska, Clinic for Infectious Diseases

Banja Luka, Republika Srpska, Bosnia and Herzegovina

University Clinical Centre Sarajevo, Clinic for Infectious Diseases

Sarajevo, Sarajevo Canton, Bosnia and Herzegovina

Clinical Center of Montenegro, Clinic for Infectious Diseases

Podgorica, Podgorica Municipality, Montenegro

Te Toka Tumai Auckland, Auckland City Hospital

Auckland, New Zealand

Aotearoa Clinical Trial Trust, Esme Green Building, Middlemore Hospital

Auckland, New Zealand

Christchurch Hospital, 2 Riccarton Avenue,

Christchurch, New Zealand

MRINZ, 7 CSB Building, Wellington Hospital

Wellington, New Zealand

University Clinical Centre Nis, Clinic for Infectious Diseases

Niš, Nišava District, Serbia

Health Center Uzice, General Hospital Uzice

Užice, Zlatibor District, Serbia

University Clinical Centre of Serbia, Clinic for Infectious Diseases

Belgrade, Serbia