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AzTrials

Healthy VolunteersPhase 1NCT05129644

Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

A Phase 1 study testing P1101 (24 mcg), P1101 (48 mcg) and P1101 (90 mcg) in people with Healthy Volunteers, run by PharmaEssentia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
P1101 (24 mcg), P1101 (48 mcg) and P1101 (90 mcg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
7 Nov 2009to 26 Jun 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Anapharm

    Québec

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
P1101 (24 mcg), P1101 (48 mcg), P1101 (90 mcg), P1101 (180 mcg), P1101 (225 mcg)
Keywords
P1101, phase 1, healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • P1101 (180 mcg)Drug

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

  • P1101 (225 mcg)Drug

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

  • P1101 (270 mcg)Drug

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

  • PegasysDrug

    Also called peginterferon alfa-2a

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

Study groups in NCT05129644
Study groupRoleWhat they receive
P1101 24 mcgExperimentalA total of 6 subjects received single dose of 24 mcg P1101
Receives: Drug: P1101 (24 mcg)
P1101 48 mcgExperimentalA total of 6 subjects received single dose of 48 mcg P1101
Receives: Drug: P1101 (48 mcg)
P1101 90 mcgExperimentalA total of 6 subjects received single dose of 90 mcg P1101
Receives: Drug: P1101 (90 mcg)
P1101 180 mcgExperimentalA total of 6 subjects received single dose of 180 mcg P1101
Receives: Drug: P1101 (180 mcg)
P1101 225 mcgExperimentalA total of 6 subjects received single dose of 225 mcg P1101
Receives: Drug: P1101 (225 mcg)
P1101 270 mcgExperimentalA total of 6 subjects received single dose of 270 mcg P1101
Receives: Drug: P1101 (270 mcg)
Pegasys 180 mcgActive comparatorA total of 12 subjects received single dose of 180 mcg Pegasys
Receives: Drug: Pegasys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event

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

    Measured: Through study Day 35

  2. AUC of P1101 and Pegasys

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

    Measured: 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.

  3. AUC0-t of P1101 and Pegasys

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

    Measured: 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.

  4. Cmax of P1101 and Pegasys

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

    Measured: 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.

  5. Ct of P1101 and Pegasys

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

    Measured: 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.

  6. Tmax of P1101 and Pegasys

    The time that Cmax was observed

    Measured: 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.

  7. T½ of P1101 and Pegasys

    Terminal elimination half-life

    Measured: 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.

  8. 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

    Measured: 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)

  1. 2',5' oligoadenylate synthetase (OAS): Emax

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

    Measured: 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. 2',5' oligoadenylate synthetase (OAS): Tmax

    The time that Emax was observed.

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

  3. 2',5' oligoadenylate synthetase (OAS): AUC0-t

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

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

  4. Neopterin: Emax

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

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

  5. Neopterin: Tmax

    The time that Emax was observed.

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

  6. Neopterin: AUC0-t

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start7 Nov 2009
  3. Primary completion26 Jun 2010
  4. Study completion26 Jun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05129644
Sponsor's protocol ID
A09-102
Status last verified
Jan 2022
First submitted
2 Nov 2021
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34907578

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P1101 (24 mcg), P1101 (48 mcg) and P1101 (90 mcg) in people with Healthy Volunteers, run by PharmaEssentia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: Through study Day 35). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05129644, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.

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