NCT05016687

First-in-human Clinical Trial Evaluating CUR-N399 in Healthy Volunteers.

A Randomised, Double-blind, Single-centre, Placebo-controlled, First-in-human Clinical Trial Evaluating the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of CUR-N399 in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Curovir AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the trial is to evaluate CUR-N399, a PI4KB inhibitor, in a first-in-human trial to evaluate the safety, tolerability and pharmacokinetics profile of single and multiple ascending doses in healthy adults. In the SAD part of the trial, single oral doses of CUR-N399 will be administered in 5 sequential cohorts. In all cohorts, safety and PK will be assessed before and after dose. Exploratory nasopharyngeal swab for assessment of airway infectants will be performed before dose and in the morning of Day 3. In SAD part Cohort 4: A urine sample will be taken from the first morning void on Day 1 and urine will be collected for potential quantification of CUR-N399 (and metabolites) during the first 24 hours post-dose. The MAD part of the trial will explore multiple ascending dosing of CUR-N399. The initial dose, dose escalation and dosing schedule will be based on emerging knowledge of safety, tolerability and PK of CUR-N399 observed in the SAD part of the trial. CUR-N399 will be administered in 3 sequential cohorts. An additional MAD cohort will evaluate CUR-N399 in older adults ≥65 years. All SAD and MAD cohorts will evaluate 8 subjects. Within each cohort, subjects will be randomised in a 3:1 ratio to receive CUR-N399 (n=6) or placebo (n=2) in a blinded fashion.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Enterovirus Infections
• Rhinovirus

Interventions

Type	Name	Description
DRUG	CUR-N399	CUR-N399 will be administered as oral capsules.
DRUG	Placebo	Placebo capsules matching CUR-N399 will administered.

Timeline

• Start date: 2021-07-22
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2021-08-23
• Last updated: 2022-03-23

Locations

1 site across 1 country: Sweden