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Pharmacokinetics, Tolerability and Safety of NEX-18a

NCT05048498 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-10-17

No results posted yet for this study

Summary

The study will evaluate the safety, tolerability and pharmacokinetics of NEX-18a, a long-acting injectable azacitidine, in patients diagnosed with intermediate 2 or higher-risk MDS, CMML, or AML and already on treatment with azacitidine.

Conditions

  • Myelodysplastic Syndromes (MDS)
  • Chronic Myelomonocytic Leukemia (CMML)
  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

NEX-18a injection

In Treatment phase 1, NEX-18a will be given as a single subcutaneous injection. In Treatment phase 2, NEX-18a will be given as a single subcutaneous injection.

DRUG

Azacitidine Injection

In Treatment phase 1, azacitidine will be administered once daily for four days. In Treatment phase 2, azacitidine will be administered once daily for three days.

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Nanexa AB

    lead INDUSTRY

Principal Investigators

  • Ulla Olsson Strömberg, MD · Uppsala University, Uppsala, Sweden

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-27
Primary Completion
2022-02-10
Completion
2022-02-10

Countries

  • Sweden

Study Locations

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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 NCT05048498 on ClinicalTrials.gov