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

Primary Purpose

Drug Kinetics, Drug Effects on Physiology

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

sargramostim

About this trial

This is an interventional basic science trial for Drug Kinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

AltaSciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Arm Label

Cohort 1 (Part 1)

Cohort 2 (Part 1)

Cohort 3 (Part 1)

Cohort 4 (Part 1)

Cohort 5 (Part 1)

Cohort 6 (Part 1)

Cohort 7 (Part 2)

Arm Description

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

Single dose of 25 mcg sargramostim SC

Single dose of 125 mcg sargramostim SC

Single dose of 250 mcg sargramostim SC

Single dose of 500 mcg sargramostim SC

Single dose of 250 mcg sargramostim IH

Two doses of 500 mg sargramostim SC, weekly

Outcomes

Primary Outcome Measures

maximum concentration

time to maximum

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

AUC from time 0 to infinity

AUC from time 0 to 24 hours/infinity

Elimination half-life

Clearance

Steady state volume of distribution (IV administration only)

Secondary Outcome Measures

Number of subjects with adverse events in Part 1

Number of subjects with adverse events in Part 2

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

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

Full Information

NCT ID

NCT05366283

First Posted

May 4, 2022

Last Updated

September 30, 2022

Sponsor

Partner Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05366283

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

April 13, 2022 (Actual)

Primary Completion Date

May 27, 2022 (Actual)

Study Completion Date

June 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Partner Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Kinetics, Drug Effects on Physiology

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 (Part 1)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2 (Part 1)

Arm Type

Experimental

Arm Description

Single dose of 25 mcg sargramostim SC

Arm Title

Cohort 3 (Part 1)

Arm Type

Experimental

Arm Description

Single dose of 125 mcg sargramostim SC

Arm Title

Cohort 4 (Part 1)

Arm Type

Experimental

Arm Description

Single dose of 250 mcg sargramostim SC

Arm Title

Cohort 5 (Part 1)

Arm Type

Experimental

Arm Description

Single dose of 500 mcg sargramostim SC

Arm Title

Cohort 6 (Part 1)

Arm Type

Experimental

Arm Description

Single dose of 250 mcg sargramostim IH

Arm Title

Cohort 7 (Part 2)

Arm Type

Experimental

Arm Description

Two doses of 500 mg sargramostim SC, weekly

Intervention Type

Biological

Intervention Name(s)

sargramostim

Other Intervention Name(s)

Leukine®, rhu-GM-CSF

Intervention Description

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

Primary Outcome Measure Information:

Title

maximum concentration

Time Frame