HealthyPhase 1NCT04923282

Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects

A Phase 1 study testing single 1-hour IV infusion of 0.8 mg/kg recAP, single 1-hour IV infusion of 1.6 mg/kg recAP and single 1-hour IV infusion of 3.2 mg/kg recAP in people with Healthy, run by AM-Pharma at 1 site in Japan.

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

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. Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: single 1-hour IV infusion of 0.8 mg/kg recAP, single 1-hour IV infusion of 1.6 mg/kg recAP and single 1-hour IV infusion of 3.2 mg/kg recAP
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteJapan
Study dates: 7 May 2021to 31 Dec 2021
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 20 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-One Clinic, Keikokai Medical Corporation
Tokyo, 192-0071

Other trials in Japan

About this study

Official title: A Double Blind, Randomized, Single Center, Single and Multiple Dose, Pharmacokinetic, Safety and Tolerability Study of Recombinant Human Alkaline Phosphatase (recAP) Administered Intravenously in Healthy Japanese Subjects

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.

Read the detailed description

This study is a randomized, double blind, parallel group, single-center trial, consisting of a single dose part and a multiple dose part in 32 healthy Japanese subjects. Since all these doses have been studied before and safety extensively evaluated in non-Japanese subjects and no ethnic sensitivity is expected, the groups can be dosed in parallel.

Part A will have 3 parallel groups of 8 male subjects with N=6 on active and N=2 on placebo per group. Following baseline assessments, a single dose of recAP will be administered by a one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety assessments.

Part B will have a single group of 8 male subjects with N=6 on active and N=2 on placebo. Following baseline assessments, recAP will be dosed on Days 1, 2 and 3 by one-hour infusions followed by samplings for pharmacokinetic evaluation and routine safety assessments.

Conditions: Healthy
Being tested: single 1-hour IV infusion of 0.8 mg/kg recAP, single 1-hour IV infusion of 1.6 mg/kg recAP, single 1-hour IV infusion of 3.2 mg/kg recAP, 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3, Placebo

What participants receive

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

single 1-hour IV infusion of 0.8 mg/kg recAPBiological
Intravenous infusion
single 1-hour IV infusion of 1.6 mg/kg recAPBiological
Intravenous infusion
single 1-hour IV infusion of 3.2 mg/kg recAPBiological
Intravenous infusion
1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3Biological
Intravenous infusion
PlaceboBiological
Intravenous infusion

Study groups in NCT04923282
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3; Biological: Placebo

What is being measured

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

Maximum observed recAP plasma concentration (Cmax) after single dose
Blood collection for cmax evaluation daily from Day 1 to Day 9
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Multiple doses 13 days treatment phase

Secondary outcomes (2)

Adverse events (AEs) after single dose
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
Measured: Single dose 9 days treatment phase
Adverse events (AEs) after multiple doses
Any untoward medical occurrence in a subject enrolled into a clinical study regardless of its causal relationship to study drug.
Measured: Multiple doses 13 days treatment phase

Timeline

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

7 May 202131 Dec 2021

First posted11 Jun 2021
Study start7 May 2021
Primary completion8 Jul 2021
Study completion31 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04923282
Sponsor's protocol ID: AP-recAP-AKI-01-02
Status last verified: Mar 2022
First submitted: 25 May 2021
Last updated: 14 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double Blind, Randomized, Single Center, Single and Multiple Dose, Pharmacokinetic, Safety and Tolerability Study of Recombinant Human Alkaline Phosphatase (recAP) Administered Intravenously in Healthy Japanese Subjects
ClinicalTrials.gov ID: NCT04923282
Acronym / sponsor ID: AP-recAP-AKI-01-02
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: AM-PharmaIndustry (pharma, biotech, devices)
Study start: 7 May 2021 (actual)
Primary completion: 8 Jul 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 11 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1: single 1-hour IV infusion of 0.8 mg/kg recAP or placebo	Active comparator	Biological: single 1-hour IV infusion of 0.8 mg/kg recAP, Biological: Placebosingle 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	Active comparator	Biological: single 1-hour IV infusion of 1.6 mg/kg recAP, Biological: Placebosingle 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	Active comparator	Biological: single 1-hour IV infusion of 3.2 mg/kg recAP, Biological: Placebosingle 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	Active comparator	Biological: 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3, Biological: Placebo1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
single 1-hour IV infusion of 0.8 mg/kg recAPIntravenous infusion	Biological	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 recAPIntravenous infusion	Biological	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 recAPIntravenous infusion	Biological	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 3Intravenous infusion	Biological	Group 4: 1-hour infusions of 1.6 mg/kg recAP or placebo on Days 1, 2 and 3
PlaceboIntravenous infusion	Biological	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

Primary outcome

Maximum observed recAP plasma concentration (Cmax) after single dose
Time frame: Single dose 9 days treatment phase
Blood collection for cmax evaluation daily from Day 1 to Day 9
Time to attain maximum recAP serum concentration (Tmax) after single dose
Time frame: Single dose 9 days treatment phase
Blood collection for Tmax evaluation daily from Day 1 to Day 9
Area under the plasma concentration versus time curve (AUC) after single dose
Time frame: Single dose 9 days treatment phase
Blood collection for AUC evaluation daily from Day 1 to Day 9
recAP elimination half-life ( t1/2) after single dose
Time frame: Single dose 9 days treatment phase
Blood collection for t1/2 evaluation daily from Day 1 to Day 9
Maximum observed recAP plasma concentration (Cmax) after multiple doses
Time frame: Multiple doses 13 days treatment phase
Blood collection for cmax evaluation daily from Day 1 to Day 13
Time to attain maximum recAP serum concentration (Tmax) after multiple doses
Time frame: Multiple doses 13 days treatment phase
Blood collection for Tmax evaluation daily from Day 1 to Day 13
Area under the plasma concentration versus time curve (AUC) after multiple doses
Time frame: Multiple doses 13 days treatment phase
Blood collection for AUC evaluation daily from Day 1 to Day 13
recAP elimination half-life ( t1/2) after multiple doses
Time frame: Multiple doses 13 days treatment phase
Blood collection for t1/2 evaluation daily from Day 1 to Day 13

2 secondary outcomes

Adverse events (AEs) after single dose
Time frame: Single dose 9 days treatment phase
Adverse events (AEs) after multiple doses
Time frame: Multiple doses 13 days treatment phase

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Annelies Legters study director

AM-Pharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. 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 14 Mar 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 Japan. 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?

Maximum observed recAP plasma concentration (Cmax) after single dose (time frame: Single dose 9 days treatment phase). 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 NCT04923282.

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 14 Mar 2022.