Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-31 @ 7:57 PM
Study NCT ID:
NCT06698861
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
Sponsor:
PharmaEssentia
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P2203 phase I
Brief Summary:
The goal of this study type: PK clinical trial is to evaluate the safety, tolerability, and pharmacokinetics/ pharmacodynamics of PEG-MetHuG-CSF (P2203) in Healthy Volunteers.
Primary objective:
‧ To evaluate the safety and tolerability of P2203
Secondary objectives:
‧ To characterize the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of P2203
Approximately 30 healthy volunteers will be enrolled. Subjects will be screened within 28 days before study dosing. Eligible subjects will be sequentially enrolled into 2 escalating-dose cohorts (Cohort 1 and 2) to receive a single dose of P2203 at a pre-determined specific dose or to re-ceive a single dose of 6 mg pegfilgrastim (Neulasta).
Primary objective:
‧ To evaluate the safety and tolerability of P2203
Secondary objectives:
‧ To characterize the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of P2203
Approximately 30 healthy volunteers will be enrolled. Subjects will be screened within 28 days before study dosing. Eligible subjects will be sequentially enrolled into 2 escalating-dose cohorts (Cohort 1 and 2) to receive a single dose of P2203 at a pre-determined specific dose or to re-ceive a single dose of 6 mg pegfilgrastim (Neulasta).
Detailed Description:
Subjects will be sequentially enrolled into the following inter-subject dose escalation cohorts:
* Cohort 1 (6 subjects): single dose of P2203 at 2 mg
* Cohort 2 (24 subjects): subjects in Cohort 2 will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 sub-jects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects).
In Cohort 1, the first two subjects will be the sentinel subjects treated with staggered dosing. The 1st sentinel subject of Cohort 1 will be dosed at least 96 hours prior to the 2nd sentinel subject. The 2nd sentinel subject will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort (Section 3.5) is not met at least during the first 96 hours following administration of P2203 of the 1st sentinel subject. The remaining subject in Cohort 1 will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort is not met at least during the first 96 hours following administration of P2203 of the 2nd sentinel subject.
In Cohort 2a, the first three subjects will be the sentinel subjects treated with staggered dosing. The rule and time interval for the stagger dosing in the sentinel subjects in Cohort 2a are the same as those in Cohort 1.
In Cohort 2, subjects will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 subjects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects).
* Cohort 1 (6 subjects): single dose of P2203 at 2 mg
* Cohort 2 (24 subjects): subjects in Cohort 2 will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 sub-jects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects).
In Cohort 1, the first two subjects will be the sentinel subjects treated with staggered dosing. The 1st sentinel subject of Cohort 1 will be dosed at least 96 hours prior to the 2nd sentinel subject. The 2nd sentinel subject will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort (Section 3.5) is not met at least during the first 96 hours following administration of P2203 of the 1st sentinel subject. The remaining subject in Cohort 1 will receive P2203 when the Criteria for Dosing Suspension or Termination in a Given Dose Cohort is not met at least during the first 96 hours following administration of P2203 of the 2nd sentinel subject.
In Cohort 2a, the first three subjects will be the sentinel subjects treated with staggered dosing. The rule and time interval for the stagger dosing in the sentinel subjects in Cohort 2a are the same as those in Cohort 1.
In Cohort 2, subjects will be randomized in a 1:1 ratio to receive a single dose of 6 mg P2203 (Cohort 2a, 12 subjects) or a single dose of 6 mg pegfilgrastim (Cohort 2b, 12 subjects).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: