Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

NCT04923282 | Completed Phase 1

• 1 other identifier: AP-recAP-AKI-01-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and tolerability of recAP after single and multiple intravenous doses in healthy Japanese subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Maximum observed recAP plasma concentration (Cmax) after single dose

  Blood collection for cmax evaluation daily from Day 1 to Day 9

  Single dose 9 days treatment phase

• Time to attain maximum recAP serum concentration (Tmax) after single dose

  Blood collection for Tmax evaluation daily from Day 1 to Day 9

  Single dose 9 days treatment phase

• Area under the plasma concentration versus time curve (AUC) after single dose

  Blood collection for AUC evaluation daily from Day 1 to Day 9

  Single dose 9 days treatment phase

• recAP elimination half-life ( t1/2) after single dose

  Blood collection for t1/2 evaluation daily from Day 1 to Day 9

  Single dose 9 days treatment phase

• Maximum observed recAP plasma concentration (Cmax) after multiple doses

  Blood collection for cmax evaluation daily from Day 1 to Day 13

  Multiple doses 13 days treatment phase

• Time to attain maximum recAP serum concentration (Tmax) after multiple doses

  Blood collection for Tmax evaluation daily from Day 1 to Day 13

  Multiple doses 13 days treatment phase

• Area under the plasma concentration versus time curve (AUC) after multiple doses

  Blood collection for AUC evaluation daily from Day 1 to Day 13

  Multiple doses 13 days treatment phase

• recAP elimination half-life ( t1/2) after multiple doses

  Blood collection for t1/2 evaluation daily from Day 1 to Day 13

  Multiple doses 13 days treatment phase

Secondary Outcomes (2)

• Adverse events (AEs) after single dose

  Single dose 9 days treatment phase

• Adverse events (AEs) after multiple doses

  Multiple doses 13 days treatment phase

Study Arms (4)

Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo

ACTIVE COMPARATOR

single 1-hour IV infusion of 0.8 mg/kg recAP or placebo

Biological: single 1-hour IV infusion of 0.8 mg/kg recAP; Biological: Placebo

Group 2: single 1-hour IV infusion of 1.6 mg/kg recAP or placebo

ACTIVE COMPARATOR

single 1-hour IV infusion of 1.6 mg/kg recAP or placebo

Biological: single 1-hour IV infusion of 1.6 mg/kg recAP; Biological: Placebo

Group 3: single 1-hour IV infusion of 3.2 mg/kg recAP or placebo

ACTIVE COMPARATOR

single 1-hour IV infusion of 3.2 mg/kg recAP or placebo

Biological: single 1-hour IV infusion of 3.2 mg/kg recAP; Biological: Placebo

Group 4: 1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3

ACTIVE COMPARATOR

1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3

Biological: 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3; Biological: Placebo

Interventions

single 1-hour IV infusion of 0.8 mg/kg recAP BIOLOGICAL

Intravenous infusion

Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo

single 1-hour IV infusion of 1.6 mg/kg recAP BIOLOGICAL

Intravenous infusion

Group 2: single 1-hour IV infusion of 1.6 mg/kg recAP or placebo

single 1-hour IV infusion of 3.2 mg/kg recAP BIOLOGICAL

Intravenous infusion

Group 3: single 1-hour IV infusion of 3.2 mg/kg recAP or placebo

1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3 BIOLOGICAL

Intravenous infusion

Group 4: 1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3

Placebo BIOLOGICAL

Intravenous infusion

Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo; Group 2: single 1-hour IV infusion of 1.6 mg/kg recAP or placebo; Group 3: single 1-hour IV infusion of 3.2 mg/kg recAP or placebo; Group 4: 1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3

Eligibility Criteria

• Age: 20 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender : male
• Age : 20-55 years, inclusive
• Body mass index (BMI) : 18.0-30.0 kg/m2, inclusive
• Subjects must be Japanese by birth, have resided outside Japan \<10 years, have parents and maternal and paternal grandparents who are Japanese, and primarily consume a Japanese diet.
• Resting supine blood pressure at screening showing no clinically relevant deviations from normal as judged by the Principal Investigator.
• Computerized (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations.
• All values for hematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Investigator.
• Ability and willingness to abstain from alcohol and tobacco products from 48 h prior to entry in the clinical research center until discharge.
• Easily accessible veins for venipuncture and catheter placing.
• Willingness to sign the written informed consent form (ICF).
• Subjects must agree to use adequate contraception when sexually active. This applies for the time period between end of first administration and 14 days after the last administration of study drug.

You may not qualify if:

• Evidence of clinically relevant pathology.
• History of relevant drug and/or food allergies.
• Subject has a history of clinically significant abnormalities or of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• Use of medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entry into the clinical research center (after that time the use of a limited amount of acetaminophen is permitted after consultation with the Principal Investigator).
• Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year.
• Participation in a drug study within 60 days prior to drug administration.
• Donation of more than 500 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 liters of blood (for men) in the 10 months preceding the start of this study
• Smoking more than 5 cigarettes, 1 cigar or 1 pipe daily.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
• Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants) and/or alcohol breath test at Screening and/or Pre-Dose.
• Intake of more than 14 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine/Japanese Sake or 35 mL of spirits).
• Positive screen on hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or anti-human immunodeficiency virus (anti-HIV)-1 or anti-HIV-2 or HIV-1/2 antigen.
• Illness within 5 days prior to (the first) drug administration.

Sponsors & Collaborators

• AM-Pharma: lead

Study Sites (1)

P-One Clinic, Keikokai Medical Corporation

Tokyo, 192-0071, Japan

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Annelies Legters

  AM-Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 11, 2021
• Study Start: May 7, 2021
• Primary Completion: July 8, 2021
• Study Completion: December 31, 2021
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)