Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

PharmaEssentia48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

P1101 (24 mcg)DRUG

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

P1101 (48 mcg)DRUG

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

P1101 (90 mcg)DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Anapharm

Québec, Canada

Outcomes

Primary Outcomes

Adverse Event

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

Time frame: Through study Day 35

AUC of P1101 and Pegasys

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

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

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