NCT05129644

Brief Summary

This was a single-center, double-blind, randomized, active control, single dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of P1101 in 48 healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2010

Completed
11.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

November 2, 2021

Last Update Submit

January 14, 2022

Conditions

Healthy Volunteers

Keywords

P1101, phase 1, healthy volunteers

Outcome Measures

Primary Outcomes (8)

  • Adverse Event

    Frequency and severity of all adverse events among subjects, including frequency and severity of drug-related adverse events.

    Through study Day 35

  • AUC of P1101 and Pegasys

    Area under the serum concentration-time curve from time 0 to infinity

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • AUC0-t of P1101 and Pegasys

    Area under the serum concentration-time curve from time zero to the last measurable concentration (AUC0-t)

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • Cmax of P1101 and Pegasys

    Maximum serum concentration; the highest concentration observed during a dosage interval.

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • Ct of P1101 and Pegasys

    The last measured serum concentration, the last concentration above the lower limit of quantification following dose

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • Tmax of P1101 and Pegasys

    The time that Cmax was observed

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • T½ of P1101 and Pegasys

    Terminal elimination half-life

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

  • λz (Ke) of P1101 and Pegasys

    The terminal elimination rate constant; calculated using linear regression on the terminal portion of the Ln-concentration versus time curve

    Samples were collected within 1 hour pre-dose, and at 1, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 240, 288, 336, 504, and 672 hours post-dose.

Secondary Outcomes (6)

  • 2',5' oligoadenylate synthetase (OAS): Emax

    Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

  • 2',5' oligoadenylate synthetase (OAS): Tmax

    Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

  • 2',5' oligoadenylate synthetase (OAS): AUC0-t

    Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

  • Neopterin: Emax

    Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

  • Neopterin: Tmax

    Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

  • +1 more secondary outcomes

Other Outcomes (1)

  • Immunogenicity

    Samples were collected within 1 hour pre-dose, at 336 and 672 hours after dose administration

Study Arms (7)

P1101 24 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 24 mcg P1101

Drug: P1101 (24 mcg)

P1101 48 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 48 mcg P1101

Drug: P1101 (48 mcg)

P1101 90 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 90 mcg P1101

Drug: P1101 (90 mcg)

P1101 180 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 180 mcg P1101

Drug: P1101 (180 mcg)

P1101 225 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 225 mcg P1101

Drug: P1101 (225 mcg)

P1101 270 mcg

EXPERIMENTAL

A total of 6 subjects received single dose of 270 mcg P1101

Drug: P1101 (270 mcg)

Pegasys 180 mcg

ACTIVE COMPARATOR

A total of 12 subjects received single dose of 180 mcg Pegasys

Drug: Pegasys

Interventions

P1101 (24 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 24 mcg subcutaneously.

P1101 24 mcg
P1101 (48 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 48 mcg subcutaneously.

P1101 48 mcg
P1101 (90 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 90 mcg subcutaneously.

P1101 90 mcg
P1101 (180 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 180 mcg subcutaneously.

P1101 180 mcg
P1101 (225 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 225 mcg subcutaneously.

P1101 225 mcg
P1101 (270 mcg)DRUG

P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 270 mcg subcutaneously.

P1101 270 mcg
PegasysDRUG

Pegasys for injection, 180 mcg/mL, 1.0 mL/vial, Dose/subject: 180 mcg subcutaneously.

Also known as: peginterferon alfa-2a
Pegasys 180 mcg

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be healthy males, non-smokers, ≥18 and ≤45 years of age;
  • Able to attend all scheduled visits and to comply with all study procedures.

You may not qualify if:

  • Clinically significant illness or surgery within 4 weeks prior to dosing;
  • Any clinically significant abnormality or abnormal laboratory test results found during screening;
  • Positive test for hepatitis B, hepatitis C, or HIV at screening;
  • Clinically significant vital sign abnormalities at screening;
  • History of significant alcohol or drug abuse within one year prior to the screening visit;
  • History of severe allergic or hypersensitivity reactions;
  • Use of an investigational drug or participation in an investigational drug trial within the last 4 weeks;
  • Any clinically significant history or presence of neurological, cardiovascular, pulmonary, hematological, immunologic, metabolic or other uncontrolled systemic disease;
  • Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety, and sleep disorders;
  • Body organ transplant and are taking immunosuppressants;
  • History of malignant disease;
  • History or presence of endocrine disorders;
  • History of coagulation disorders and blood dyscrasias;
  • Inability to comprehend the written consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anapharm

Québec, Canada

Location

Related Publications (1)

  • Huang YW, Qin A, Fang J, Wang TF, Tsai CW, Lin KC, Teng CL, Larouche R. Novel long-acting ropeginterferon alfa-2b: Pharmacokinetics, pharmacodynamics and safety in a phase I clinical trial. Br J Clin Pharmacol. 2022 May;88(5):2396-2407. doi: 10.1111/bcp.15176. Epub 2021 Dec 28.

    PMID: 34907578RESULT

MeSH Terms

Interventions

peginterferon alfa-2a

Study Officials

  • Richard Larouche, MD

    Anapharm 5160, boul. Décarie, suite 800 Montréal, Québec, Canada, H3X 2H9

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: This was a single center, double-blind, randomized, active control, single dose escalation study, with P1101 (24, 48, 90, 180, 225, 270 mcg) as the test drug and Pegasys (180 ug) as the control drug.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 22, 2021

Study Start

November 7, 2009

Primary Completion

June 26, 2010

Study Completion

June 26, 2010

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)