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Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Sponsor
PharmaEssentia (Industry)
Overall Status
Completed
CT.gov ID
NCT05129644
Collaborator
(none)
48
Enrollment
1
Location
7
Arms
7.6
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: P1101 (24 mcg)
  • Drug: P1101 (48 mcg)
  • Drug: P1101 (90 mcg)
  • Drug: P1101 (180 mcg)
  • Drug: P1101 (225 mcg)
  • Drug: P1101 (270 mcg)
  • Drug: Pegasys
 Phase 1

Detailed Description

The primary objectives were to determine the safety and tolerability of single ascending subcutaneous doses of P1101 and to determine the pharmacokinetics of P1101 in single ascending subcutaneous doses of P1101 in healthy male subjects.

The secondary objectives were to evaluate the occurrence of side effects in healthy subjects receiving either P1101 or PEGASYS; to compare the pharmacokinetic parameters for P1101 and PEGASYS; and to assess the effect of P1101 on the biomarkers 2',5' oligoadenylate synthetase and neopterin.

A total of 48 subjects were enrolled to receive subcutaneous injection of P1101 in the dose level of 24 , 48 , 90 , 180 , 225 , or 270 mcg or to receive subcutaneous injection of 180 mcg Pegasys.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Phase I, Randomized Double-Blind, Active Control, Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects
Actual Study Start Date :
Nov 7, 2009
Actual Primary Completion Date :
Jun 26, 2010
Actual Study Completion Date :
Jun 26, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: P1101 24 mcg

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

Drug: P1101 (24 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 24 mcg subcutaneously.
Experimental: P1101 48 mcg

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

Drug: P1101 (48 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 48 mcg subcutaneously.
Experimental: P1101 90 mcg

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

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

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

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

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

Drug: P1101 (225 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 225 mcg subcutaneously.
Experimental: P1101 270 mcg

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

Drug: P1101 (270 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 270 mcg subcutaneously.
Active Comparator: Pegasys 180 mcg

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

Drug: Pegasys
Pegasys for injection, 180 mcg/mL, 1.0 mL/vial, Dose/subject: 180 mcg subcutaneously.
Other Names:
  • peginterferon alfa-2a

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Event [Through study Day 35]

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

    2. AUC of P1101 and Pegasys [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.]

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

    3. AUC0-t of P1101 and Pegasys [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.]

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

    4. Cmax of P1101 and Pegasys [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.]

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

    5. Ct of P1101 and Pegasys [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.]

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

    6. Tmax of P1101 and Pegasys [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.]

      The time that Cmax was observed

    7. T½ of P1101 and Pegasys [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.]

      Terminal elimination half-life

    8. λz (Ke) of P1101 and Pegasys [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.]

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

    Secondary Outcome Measures

    1. 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]

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

    2. 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]

      The time that Emax was observed.

    3. 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]

      Area under the biomarker concentration versus time curve from time 0 to the last measured concentration.

    4. 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]

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

    5. 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]

      The time that Emax was observed.

    6. Neopterin: 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]

      Area under the biomarker concentration versus time curve from time 0 to the last measured concentration.

    Other Outcome Measures

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

      Analysis of the concentration of anti-P1101 antibody.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Main Inclusion Criteria:

    1. Be healthy males, non-smokers, ≥18 and ≤45 years of age;

    2. Able to attend all scheduled visits and to comply with all study procedures.

    Main Exclusion Criteria:

    1. Clinically significant illness or surgery within 4 weeks prior to dosing;

    2. Any clinically significant abnormality or abnormal laboratory test results found during screening;

    3. Positive test for hepatitis B, hepatitis C, or HIV at screening;

    4. Clinically significant vital sign abnormalities at screening;

    5. History of significant alcohol or drug abuse within one year prior to the screening visit;

    6. History of severe allergic or hypersensitivity reactions;

    7. Use of an investigational drug or participation in an investigational drug trial within the last 4 weeks;

    8. Any clinically significant history or presence of neurological, cardiovascular, pulmonary, hematological, immunologic, metabolic or other uncontrolled systemic disease;

    9. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety, and sleep disorders;

    10. Body organ transplant and are taking immunosuppressants;

    11. History of malignant disease;

    12. History or presence of endocrine disorders;

    13. History of coagulation disorders and blood dyscrasias;

    14. Inability to comprehend the written consent form.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anapharm Québec Canada

    Sponsors and Collaborators

    • PharmaEssentia

    Investigators

    • Principal Investigator: Richard Larouche, MD, Anapharm 5160, boul. Décarie, suite 800 Montréal, Québec, Canada, H3X 2H9

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    PharmaEssentia
    ClinicalTrials.gov Identifier:
    NCT05129644
    Other Study ID Numbers:
    • A09-102
    First Posted:
    Nov 22, 2021
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by PharmaEssentia
    P1101, phase 1, healthy volunteers
    Additional relevant MeSH terms:
    Peginterferon alfa-2a

    Study Results

    No Results Posted as of Jan 18, 2022