Status:
COMPLETED
Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of Sargramostim Administered Subcutaneously, Intravenously, or by Inhalation
Lead Sponsor:
Partner Therapeutics, Inc.
Conditions:
Drug Kinetics
Drug Effects on Physiology
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05366283
Start Date
April 13 2022
End Date
June 16 2022
Last Update
October 3 2022
Active Locations (1)
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1
AltaSciences
Mount Royal, Quebec, Canada, H3P 3P1