NCT05366283 is a Phase 1 clinical trial of sargramostim in Drug Kinetics, sponsored by Partner Therapeutics, Inc..

Who is sponsoring NCT05366283?

NCT05366283 is sponsored by Partner Therapeutics, Inc..

What drugs are being tested in NCT05366283?

Interventions in NCT05366283: sargramostim.

What condition does NCT05366283 study?

NCT05366283 studies Drug Kinetics, Drug Effects on Physiology.

Is NCT05366283 still recruiting?

NCT05366283 is currently completed. Last updated 3 October 2022.

Last reviewed 2022-10-03 · How we verify

NCT05366283

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 3 October 2022

What this trial tests

Phase 1 trial testing sargramostim in Drug Kinetics in 42 participants. Completed in 16 June 2022.

Timeline

13 April 2022

Primary endpoint
27 May 2022

16 June 2022

Quick facts

Lead sponsor	Partner Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	42
Start date	13 April 2022
Primary completion	27 May 2022
Estimated completion	16 June 2022
Sites	1 location across Canada

Drugs / interventions tested

sargramostim (SARGRAMOSTIM) — full drug profile →

Conditions studied

Drug Kinetics — all drugs for Drug Kinetics →
Drug Effects on Physiology — all drugs for Drug Effects on Physiology →

Sponsor

Partner Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Drug Kinetics or Drug Effects on Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of sargramostim

Trials testing the same drug.

NCT03790670 — Biomarker Assessments of Leukine During Treatment of Parkinson's Disease · Phase 1 · completed
NCT02250014 — The Immuno-Response to Primary Cryotherapy for the Treatment of Prostate Cancer · Phase 1 · completed
NCT01882010 — Leukine (Sargramostim) for Parkinson's Disease · Phase 1 · completed
NCT01536054 — Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Perit · Phase 1 · completed
NCT01826864 — Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma · Phase 3 · withdrawn

Other recruiting trials for Drug Kinetics

Currently open trials in the same condition.

NCT06757140 — Opioid Drug Interaction Study · Phase 1, PHASE2 · recruiting

Other Partner Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04707664 — Sargramostim Use in COVID-19 to Recover Patient Health · Phase 2 · completed
NCT04411680 — Study of Sargramostim in Patients With COVID-19 · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05366283 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Partner Therapeutics, Inc.
Last refreshed: 3 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05366283.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing