Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: P1101 (48 mcg); Drug: P1101 (24 mcg); Drug: P1101 (180 mcg); Drug: P1101 (270 mcg); Drug: P1101 (225 mcg); Drug: P1101 (90 mcg); Drug: Pegasys

• Registration Number: NCT05129644
• Lead Sponsor: PharmaEssentia

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2009-11-07
• Primary Completion: 2010-06-26
• Study Completion: 2010-06-26
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
P1101 48 mcg	P1101 (48 mcg)	A total of 6 subjects received single dose of 48 mcg P1101
P1101 24 mcg	P1101 (24 mcg)	A total of 6 subjects received single dose of 24 mcg P1101
P1101 180 mcg	P1101 (180 mcg)	A total of 6 subjects received single dose of 180 mcg P1101
P1101 270 mcg	P1101 (270 mcg)	A total of 6 subjects received single dose of 270 mcg P1101
P1101 225 mcg	P1101 (225 mcg)	A total of 6 subjects received single dose of 225 mcg P1101
P1101 90 mcg	P1101 (90 mcg)	A total of 6 subjects received single dose of 90 mcg P1101
Pegasys 180 mcg	Pegasys	A total of 12 subjects received single dose of 180 mcg Pegasys

Primary Outcome Measures

Name	Time	Method
Adverse Event	Through study Day 35	Frequency and severity of all adverse events among subjects, including frequency and severity of drug-related adverse events.
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
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)
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.
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
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
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
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

Name	Time	Method
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',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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Anapharm; 🇨🇦 Québec, Canada