NCT05643248

To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects

A Single Ascending Dose Pilot Study to Assess the Safety, Tolerability and Pharmacokinetics of NEX-20A Given as a Subcutaneous Prolonged-release Injection to Healthy Male Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Nanexa AB · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-centre, single ascending dose (SAD) pilot study designed to evaluate the safety, tolerability, including local tolerability, and pharmacokinetics (PK) of NEX-20A (lenalidomide) after the administration of a single subcutaneous prolonged-release injection to healthy male volunteers

Detailed description

NEX-20A will be administered in sequential cohorts, 2 standard cohorts and an optional third cohort, each comprising 3 subjects. Subjects will be dosed in a sentinel fashion, and all available safety and tolerability data up until and including 10 days for the sentinel subjects must have been evaluated by the iSRC before dosing the remaining 2 subjects in each cohort.Once safety, tolerability and PK data of the last subject in each cohort has been collected, and interim data analysis has been conducted, there must be at least 1 week between dose escalations.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	NEX-20A	Subcutaneous prolonged-release injection

Timeline

• Start date: 2022-11-28
• Primary completion: 2023-09-26
• Completion: 2023-09-26
• First posted: 2022-12-08
• Last updated: 2023-10-31

Locations

1 site across 1 country: Sweden