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OpenTrials
Completed

NCT Number: NCT05366283

Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation

This single center, single ascending dose (SAD) and repeat dose study in healthy adults comprises 2 parts. Part 1 will consist of 6 SAD cohorts, in which different dose levels of sargramostim will be given by intravenous (IV) infusion, subcutaneous (SC) injection, or inhalation (IH) administration. Part 2 will consist of 1 repeat dose cohort in which sargramostim will begiven by SC administration.

Blood samples for PK assessment will be collected before and over 24 hours after each study drug administration. Blood samples for PD assessment will be collected before and up to 14 days after drug administration in Part 1, as well as before the first and up to 14 days after the second drug administration in Part 2. Safety and tolerability will be assessed throughout the study. For Cohort 5 of Part 1 only, 3 subjects will provide a CSF sample for PK assessmen tonce after SC drug administration.

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Key information

Conditions

Drug Kinetics Drug Effects on Physiology

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

AltaSciences

Mount Royal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult male and female participants
  • Nonsmoker or ex-smoker
  • Able to provide informed consent and comply with all study procedures
  • Body Mass Index within 18.5-30.0 kilograms/meter squared, inclusive
  • Females of childbearing potential willing to use highly-effective method of birth control.

Exclusion criteria

  • Females who are pregnant or breastfeeding
  • History of allergic to sargramostim or its excipients, other human GM-CSFs, or other yeast-derived products.
  • History of severe allergic reactions to other drugs.
  • History of or any current medical condition or laboratory finding that may jeopardize completion of the study, present an increased risk to the subject, or compromise interpretation of the study. .
  • Immunization with COVID-19 vaccine within 14 days of the study.
  • Scheduled immunization with COVID-19 vaccine during the study
  • Use of prescription drugs within 28 days of the study or requirement for maintenance drugs during the study.
  • Participation in another investigational drug study within 28 days

Treatment and study plan

sargramostim

Biological

Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.

Other names: Leukine®, rhu-GM-CSF

Primary outcomes

  1. maximum concentration

    Time frame: Blood samples collected up to 24 hours post dose

  2. time to maximum

    Time frame: Blood samples collected up to 24 hours post dose

  3. Area under the concentration-time curve (AUC) from time 0 to 24 hours

    Time frame: Blood samples collected up to 24 hours post dose

  4. AUC from time 0 to infinity

    Time frame: Blood samples collected up to 24 hours post dose

  5. AUC from time 0 to 24 hours/infinity

    Time frame: Blood samples collected up to 24 hours post dose

  6. Elimination half-life

    Time frame: Blood samples collected up to 24 hours post dose

  7. Clearance

    Time frame: Blood samples collected up to 24 hours post dose

  8. Steady state volume of distribution (IV administration only)

    Time frame: Blood samples collected up to 24 hours post dose

Secondary outcomes

  1. Number of subjects with adverse events in Part 1

    Time frame: Up to Day 15 in Part 1

  2. Number of subjects with adverse events in Part 2

    Time frame: Up to Day 22 in Part 2

  3. Ratio of T-regulatory cells to T-effector cells in the blood.

    Time frame: Up to Day 15 in Part 1, up to Day 22 in Part 2

  4. CD14/CD16/human leukocyte antigen-DR isotype (HLA-DR) absolute cell count

    Time frame: Up to Day 15 in Part 1, up to Day 22 in Part 2

Sponsors and collaborators

Lead sponsor

Partner Therapeutics, Inc.

Industry

Registry information

Official study title

Single Ascending Dose and Repeat Dose Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, by Intravenous Infusion, or by Inhalation in Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 9, 2022
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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