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Cohort 4 (Part 1) for Drug Kinetics

Phase 1
Waitlist Available
Research Sponsored by Partner Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adult male and female participants
Nonsmoker or ex-smoker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 15 in part 1, up to day 22 in part 2
Awards & highlights

Study 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.

Eligible Conditions
  • Drug Kinetics
  • Physiological Effects

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 15 in part 1, up to day 22 in part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 in part 1, up to day 22 in part 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from time 0 to 24 hours/infinity
AUC from time 0 to infinity
Area under the concentration-time curve (AUC) from time 0 to 24 hours
+5 more
Secondary outcome measures
CD14/CD16/human leukocyte antigen-DR isotype (HLA-DR) absolute cell count
Number of subjects with adverse events in Part 1
Number of subjects with adverse events in Part 2
+1 more

Side effects data

From 2011 Phase 3 trial • 170 Patients • NCT00002766
17%
Fatigue
16%
Hypokalemia
15%
Febrile neutropenia
15%
Hypophosphatemia
13%
Pain, other
13%
Abdominal pain/cramping
11%
Stomatitis/pharyngitis
8%
Thrombosis
8%
Dyspnea
8%
Hypomagnesemia
7%
Dizziness
7%
Bilirubin
6%
Prothrombin Time
6%
Vision-blurred vision
6%
SGPT (ALT)
6%
Ileus (or neuroconstipation)
6%
Anorexia
6%
Hyponatremia
4%
Infection/Febrible Neutrophil-Other
3%
Hemorrhage, other
2%
Neuropathy-motor
2%
infection
2%
Platelets
2%
Pulmonary, other
2%
Renal failure
2%
Dehydration
2%
Adult respiratory disorder
1%
Gastrointestinal, other
1%
Leukocytes
1%
Dermatology, skin other
1%
Epistaxis
1%
Neutrophils (Leukemia)
1%
Constipation
1%
Diarrhea
1%
Chest pain
1%
Syncope
1%
Supraventricular tachycardia
1%
Headache
1%
disseminated intravascular coagulation
1%
Cardiovascular, Arrhythmia other
1%
Ascites
1%
ALT, SGPT
1%
Pancreatitis
1%
Supravent arrhythmia
1%
Neutrophils
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-20
All-2

Trial Design

7Treatment groups
Experimental Treatment
Group I: Cohort 7 (Part 2)Experimental Treatment1 Intervention
Two doses of 500 mg sargramostim SC, weekly
Group II: Cohort 6 (Part 1)Experimental Treatment1 Intervention
Single dose of 250 mcg sargramostim IH
Group III: Cohort 5 (Part 1)Experimental Treatment1 Intervention
Single dose of 500 mcg sargramostim SC
Group IV: Cohort 4 (Part 1)Experimental Treatment1 Intervention
Single dose of 250 mcg sargramostim SC
Group V: Cohort 3 (Part 1)Experimental Treatment1 Intervention
Single dose of 125 mcg sargramostim SC
Group VI: Cohort 2 (Part 1)Experimental Treatment1 Intervention
Single dose of 25 mcg sargramostim SC
Group VII: Cohort 1 (Part 1)Experimental Treatment1 Intervention
Single dose of 250 microgram (mcg) sargramostim IV over 2 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sargramostim
1996
Completed Phase 3
~4880

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Partner Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
859 Total Patients Enrolled
Ila Joshi, PhDStudy DirectorPartner Therapeutics, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby Mar 2025