RecruitingPhase 2NCT07633288

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

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


Sponsor

SynAct Pharma Aps

Enrollment

96 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AP1189, 100 mg and a drug called Placebo for people with respiratory viral infection. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAP1189, 100 mg

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

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07633288


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