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

Sponsor
Partner Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05366283
Collaborator
(none)
42
Enrollment
1
Location
7
Arms
1.6
Anticipated Duration (Months)
26.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: sargramostim
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official 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
Actual Study Start Date :
Apr 13, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1 (Part 1)

Single dose of 250 microgram (mcg) sargramostim IV over 2 hours

Biological: sargramostim
Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 2 (Part 1)

    Single dose of 25 mcg sargramostim SC

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 3 (Part 1)

    Single dose of 125 mcg sargramostim SC

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 4 (Part 1)

    Single dose of 250 mcg sargramostim SC

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 5 (Part 1)

    Single dose of 500 mcg sargramostim SC

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 6 (Part 1)

    Single dose of 250 mcg sargramostim IH

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•
    Experimental: Cohort 7 (Part 2)

    Two doses of 500 mg sargramostim SC, weekly

    Biological: sargramostim
    Sargramostim is a glycosylated, yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
    Other Names:
  • Leukine®
  • rhu-GM-CSF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. maximum concentration [Blood samples collected up to 24 hours post dose]

    2. time to maximum [Blood samples collected up to 24 hours post dose]

    3. Area under the concentration-time curve (AUC) from time 0 to 24 hours [Blood samples collected up to 24 hours post dose]

    4. AUC from time 0 to infinity [Blood samples collected up to 24 hours post dose]

    5. AUC from time 0 to 24 hours/infinity [Blood samples collected up to 24 hours post dose]

    6. Elimination half-life [Blood samples collected up to 24 hours post dose]

    7. Clearance [Blood samples collected up to 24 hours post dose]

    8. Steady state volume of distribution (IV administration only) [Blood samples collected up to 24 hours post dose]

    Secondary Outcome Measures

    1. Number of subjects with adverse events in Part 1 [Up to Day 15 in Part 1]

    2. Number of subjects with adverse events in Part 2 [Up to Day 22 in Part 2]

    3. Ratio of T-regulatory cells to T-effector cells in the blood. [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 [Up to Day 15 in Part 1, up to Day 22 in Part 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AltaSciences Mount-Royal Quebec Canada H3P 3P1

    Sponsors and Collaborators

    • Partner Therapeutics, Inc.

    Investigators

    • Study Director: Ila Joshi, PhD, Partner Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Partner Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05366283
    Other Study ID Numbers:
    • PTX-001-005
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Sargramostim

    Study Results

    No Results Posted as of May 27, 2022