Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 3:35 AM
Study NCT ID:
NCT06439056
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study Assessing the Pharmacokinetics of NEX-22A in Subjects With T2D
Sponsor:
Nanexa AB
Organization:
Study Overview
Official Title:
An Open, Single Ascending Dose, Phase 1 Study to Assess the Pharmacokinetics, Safety, and Tolerability of NEX-22A, a Subcutaneous Prolonged-release Injection, in Male and Female Participants With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose with the study is to assess pharmacokinetics of NEX-22A in patients with type 2 diabetes.
Detailed Description:
The trial is a single-centre, open-label, single ascending dose study. After being informed about the study and potential risks, all patients given written informed consent will undergo a screening to determine eligibility for study entry. Each subject will be enrolled in one of the three sequential cohorts, comprising one single dose of NEX-22A liraglutide injection. Each cohort will have a sentinel participant. NEX-22A will be administered in sequential cohorts. Before initiating a new dose cohort, safety, tolerability and PK data for all treated subjects must have been reviewed by the dose escalation committee. Blood samples for PK analysis will be withdrawn at specified timepoints over a period of 36 days
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: