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The Safety and Tolerability of SerpinPC in Healthy Men and in Men with Severe Blood Disorders (haemophilia a and B) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

The Safety and Tolerability of SerpinPC in Healthy Men and in Men with Severe Blood Disorders (haemophilia a and B)

An Adaptive Design, Phase I/IIa, Open Label, Multicentre, Single Dose Escalation and Multiple Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous and Subcutaneous Doses of SerpinPC in Healthy Male Volunteers and Male Participants with Severe Haemophilia a or B with or Without Inhibitors

NCT04073498•ApcinteX Ltd

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the safety and activity in the body of a new drug called SerpinPC. The study will be split into 7 parts: Part 1a will be conducted in healthy male volunteers in the UK (up to 15) and Parts 1b, 2, 3, 4, 5 and 6 will be conducted in haemophilia A \& B patients in Moldova and Georgia. Part 1a of the study will look at how safe the drug is when given as single doses to healthy volunteers at different strengths and via 2 different routes of administration (through a vein or via an injection under the skin). Parts 1b, 2, 3, 4, 5 and 6 of the study will look at the safety of the drug when given as an injection under the skin to patients with severe haemophilia A or B. The study will also investigate how the levels of the drug in the blood change over a period of time and how the drug acts in the body by taking blood samples. These blood samples will measure the concentration of the drug in the blood and measure certain aspects of the blood to determine how the drug affects them. The study sponsor (ApcinteX) is developing this drug for the treatment of haemophilia A and haemophilia B, which are 2 types of rare blood disorders which affect the body's ability to form blood clots. Patients who have haemophilia A and B do not have certain clotting factors in their blood which means that they experience difficulty in stopping bleeding after injury and can be prone to extended periods of bleeding. Current treatments for haemophilia involves injections which replace the missing factors in the blood. However these treatments are short term and therefore patients require regular treatments in order to manage the condition. Therefore, there is a need to develop more effective treatments which provide longer term benefits. The aim of SerpinPC is to prevent bleeding rather than to have to treat bleeds to minimise pain and damage after they have occurred.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1a (Healthy Subjects)
•1. Males age ≥18 years and ≤55 years.
•2. Capable of giving written informed consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or delegate.
•3. Willingness to give written consent to have data entered into The Over-volunteering Prevention System (TOPS).
•4. Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of the entire trial.
•5. Screening D-dimer ≤ 750 µg/L
•6. Non-user of nicotine products i.e. non-smokers or ex-smokers who have stopped smoking or who had stopped using cigarette replacements for at least 6 months before the first dose of IMP.
•7. Male subject willing to use 2 highly effective methods of contraception from the first dose administration until 3 months after dosing.
•8. Subject with a body mass index (BMI) of 18 - 30 kg/m2 and weight ≥ 60 kg.
•9. Subject with no clinically significant history of previous drug allergies.
+40 more criteria

Exclusion Criteria

•1. Healthy subject/patient with known thrombophilia.
•2. Healthy subject/patient with previous Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), Myocardial Infarction (MI) or stroke.
•3. Healthy subject/patient with uncontrolled hypertension (healthy subject: Systolic BP \> 140 mmHg, Diastolic BP \> 90 mmHg and patient: Systolic BP \> 160 mmHg, Diastolic BP \> 100 mmHg).
•4. Healthy subject/patient with diagnosis of diabetes requiring drug treatment.
•5. Healthy subject/patient who has active cancer or requiring therapy for cancer or diagnosis of cancer in previous 12 months before the first dose of IMP.
•6. Healthy subject who has participated in a clinical trial during the 90 days prior to dosing and patient who has participated in a clinical trial during the 30 days prior to screening.
•7. Healthy subject/patient with any major medical or psychological or psychiatric condition that could cause the healthy subject/patient to be unsuitable for the study or could interfere with the interpretation of the study results.
•8. Healthy subject/patient with a history of or other evidence of recent alcohol or drug abuse (in the previous 12 months before the first dose of IMP).
•9. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
•10. Inability to communicate well with Investigators (i.e., language problem, poor mental development or impaired cerebral function).
+17 more criteria

Locations (3)

Arensia Clinical Research Unit

Tbilisi, Georgia

Arensia Clinical Research Unit

Chisinau, Moldova

Simbec Research Ltd

Merthyr Tydfil, Cardiff, United Kingdom

Key Dates

Start Date

August 14, 2019

Primary Completion Date

September 26, 2024

Completion Date

September 26, 2024

Last Updated

February 6, 2025

Enrollment

ACTUAL participants

Conditions

Hemophilia aHemophilia B

Interventions

SerpinPC

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Safety and Tolerability of SerpinPC in Healthy Men and in Men with Severe Blood Disorders (haemophilia a and B)

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

National Longitudinal Cohort of Hematological Diseases

Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B

The Safety and Tolerability of SerpinPC in Healthy Men and in Men with Severe Blood Disorders (haemophilia a and B)

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B

A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

National Longitudinal Cohort of Hematological Diseases

Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to &lt; 18 Years of Age) With Severe or Moderately Severe Hemophilia B

Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B