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

Drug Kinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366283
• Other study ID #: PTX-001-005
• Status: Completed
• Phase: Phase 1
• Start date: April 13, 2022
• Est. completion date: June 16, 2022

Study information

• Verified date: May 2022
• Source: Partner Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 16, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Kinetics
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Canada	AltaSciences	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Partner Therapeutics, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum concentration		Blood samples collected up to 24 hours post dose
Primary	time to maximum		Blood samples collected up to 24 hours post dose
Primary	Area under the concentration-time curve (AUC) from time 0 to 24 hours		Blood samples collected up to 24 hours post dose
Primary	AUC from time 0 to infinity		Blood samples collected up to 24 hours post dose
Primary	AUC from time 0 to 24 hours/infinity		Blood samples collected up to 24 hours post dose
Primary	Elimination half-life		Blood samples collected up to 24 hours post dose
Primary	Clearance		Blood samples collected up to 24 hours post dose
Primary	Steady state volume of distribution (IV administration only)		Blood samples collected up to 24 hours post dose
Secondary	Number of subjects with adverse events in Part 1		Up to Day 15 in Part 1
Secondary	Number of subjects with adverse events in Part 2		Up to Day 22 in Part 2
Secondary	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
Secondary	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