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

NCT05643248 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-10-31

No results posted yet for this study

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

Conditions

Interventions

DRUG

NEX-20A

Subcutaneous prolonged-release injection

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Nanexa AB

    lead INDUSTRY

Principal Investigators

  • Hjalmar Flygt · CTC Clinical Trial Consultants AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-09-26
Completion
2023-09-26

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643248 on ClinicalTrials.gov