Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Healthy Volunteers Clinical Trial

Official title:

Phase I, Randomized Double-Blind, Active Control, Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05129644
• Other study ID #: A09-102
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2009
• Est. completion date: June 26, 2010

Study information

• Verified date: January 2022
• Source: PharmaEssentia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 26, 2010
• Est. primary completion date: June 26, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• P1101 (24 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 24 mcg subcutaneously.
• P1101 (48 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 48 mcg subcutaneously.
• P1101 (90 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 90 mcg subcutaneously.
• P1101 (180 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 180 mcg subcutaneously.
• P1101 (225 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 225 mcg subcutaneously.
• P1101 (270 mcg)
P1101 solution for injection, 180 mcg/mL, 1.2 mL/vial;Dose/subject: 270 mcg subcutaneously.
• Pegasys
Pegasys for injection, 180 mcg/mL, 1.0 mL/vial, Dose/subject: 180 mcg subcutaneously.

Locations

Country	Name	City	State
Canada	Anapharm	Québec

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEssentia

Country where clinical trial is conducted

Canada, 

References & 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. 2021 Dec 14. doi: 10.1111/bcp.15176. [Epub a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogenicity	Analysis of the concentration of anti-P1101 antibody.	Samples were collected within 1 hour pre-dose, at 336 and 672 hours after dose administration
Primary	Adverse Event	Frequency and severity of all adverse events among subjects, including frequency and severity of drug-related adverse events.	Through study Day 35
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	?z (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	2',5' oligoadenylate synthetase (OAS): Emax	Maximum serum biomarker response; the highest biomarker concentration observed during a dosage interval.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose
Secondary	2',5' oligoadenylate synthetase (OAS): Tmax	The time that Emax was observed.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose
Secondary	2',5' oligoadenylate synthetase (OAS): AUC0-t	Area under the biomarker concentration versus time curve from time 0 to the last measured concentration.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose
Secondary	Neopterin: Emax	Maximum serum biomarker response; the highest biomarker concentration observed during a dosage interval.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose
Secondary	Neopterin: Tmax	The time that Emax was observed.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose
Secondary	Neopterin: AUC0-t	Area under the biomarker concentration versus time curve from time 0 to the last measured concentration.	Samples were collected within 1 hour pre-dose and at 24, 48, 72, 96, 120, 168, 240, 336, 504, and 672 hours post-dose

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