AmyloidosisPhase 1NCT03879278
Multiple Ascending Dose Study in Healthy Subjects
A Phase 1 study testing NPT189 in people with Amyloidosis, run by Proclara Biosciences, Inc. at 1 site in Netherlands.
Trial summary
This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyloidosis
- What is being tested?
- NPT189
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Mar 2019to 27 Jun 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years, inclusive, at screening
- Weight 45-120 kg, inclusive
- Body Mass Index of 18.0-32.0 kg/m2, inclusive
- Female subjects of childbearing potential (defined as not surgically sterile or at least 2 years postmenopausal confirmed by a Screening Follicular Stimulating Hormone level of > 40) must agree to use two of the following forms of contraception from 60 days prior through 90 days following the dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, complete abstinence, or vasectomized partner (6 months minimum) or male subjects who are sexually active with women of childbearing potential must agree to complete abstinence or to use a condom for 90 days following the dose of study drug.
- No clinically significant abnormal findings on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory evaluation during screening; and systolic blood pressure between 140 mm and 90 mm Hg and diastolic blood pressure between 90 mm and 45 mm Hg.
- Can understand and sign the informed consent document, can communicate with the Investigator, and can understand and comply with the requirements of the protocol.
Who cannot join
- Have a past or present serious medical illness or other medical or social reason that in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Participation in a clinical trial (other than a screening visit) within 60 days of study drug administration.
- Use of any over-the-counter or prescription medication , vitamin preparations and other food supplements, or herbal medications (e.g., St. John's Wort) within 14 days prior to the dose of study drug or during the study, with the exception of hormonal contraceptives for women of childbearing potential, unless approved by the Principal Investigator or use of beta-blockers within 30 days prior to dose of study drug or during the study.
- Donation of blood or plasma within 30 days of the dose of study drug and throughout the duration of the study and for male subjects, donation of sperm through the duration of the study.
- Women who are nursing, pregnant, suspected of being pregnant, or trying to become pregnant, or are lactating, have a positive serum pregnancy test at screening or urine pregnancy test prior to administration of study drug regardless of childbearing potential.
- Positive blood screen for HIV, hepatitis B surface antigen (HbSAg), or hepatitis C as Screening, or a positive urine screen for alcohol (the day before each dose administration only) or, drugs of abuse, or cotinine at Screening and on the day before each dose administration.
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- Have clinically significant abnormalities in laboratory values as judged by the clinical investigator.
- Have a history of alcoholism and/or drug abuse.
- Unsuitable veins for infusion or blood sampling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects
This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.
Read the detailed description
This study is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability and PK study of NPT189 in healthy subjects. Three dose cohorts are planned each with a maximum of 8 subjects (6 active: 2 placebo) enrolled per cohort. Eligible subjects will be administered NPT189 by IV infusions at the dose specified for their cohort (i.e., 2 mg/kg, 5 mg/kg, and 12.5 mg/kg) or a matching placebo. Subjects will receive a total of 5 doses of NPT189, with doses administered at weekly intervals. Safety and tolerability will be assessed by analysis of adverse events (AEs), vital signs, electrocardiograms (ECG), laboratory and physical examinations. PK will be assessed by analysis of serum NPT189 concentrations.
- Conditions
- Amyloidosis
- Being tested
- NPT189
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPT189Drug
Also called IgG1 (Immunoglobulin G), Fusion Protein, GAIM (General Amyloid Interaction Motif)
NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 2 mg/kg | Other | Five IV doses of 2 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week Receives: Drug: NPT189 |
| Treatment 5 mg/kg | Other | Five IV doses of 5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week Receives: Drug: NPT189 |
| Treatment 12.5 mg/kg | Other | Five IV doses of 12.5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week Receives: Drug: NPT189 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event assessment in subjects receiving multiple intravenous infusions of NPT189
Summary of the frequency and percentage of adverse events
Measured: Day 1 through Day 112
Secondary outcomes (6)
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Cmax)
Observed maximum concentration (Cmax)
Measured: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Tmax)
Time of the maximum measured concentration (Tmax)
Measured: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189 (AUC 0-tau)
Area under the serum concentration-time curve over a dosing interval, tau
Measured: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189. Terminal elimination half-life (t 1/2)
Terminal elimination half-life (t 1/2)
Measured: Day 1 through DAy 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Clearance (CL)
Clearance (CL)
Measured: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Volume of distribution (Vd)
Apparent volume of distribution (Vd)
Measured: Day 1 through Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start6 Mar 2019
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Why it stopped: Mild infusion reactions were observed in two healthy volunteers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proclara Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Proclara Biosciences, Inc, Study director, Proclara Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879278
- Sponsor's protocol ID
- NPT189-CL002
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of NPT189 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03879278
- Acronym / sponsor ID
- NPT189-CL002
- Conditions
- Amyloidosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mild infusion reactions were observed in two healthy volunteers.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Proclara Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 18 Mar 2019 (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.
This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.
Detailed description
This study is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability and PK study of NPT189 in healthy subjects. Three dose cohorts are planned each with a maximum of 8 subjects (6 active: 2 placebo) enrolled per cohort. Eligible subjects will be administered NPT189 by IV infusions at the dose specified for their cohort (i.e., 2 mg/kg, 5 mg/kg, and 12.5 mg/kg) or a matching placebo. Subjects will receive a total of 5 doses of NPT189, with doses administered at weekly intervals. Safety and tolerability will be assessed by analysis of adverse events (AEs), vital signs, electrocardiograms (ECG), laboratory and physical examinations. PK will be assessed by analysis of serum NPT189 concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 2 mg/kg | Other | Drug: NPT189Five IV doses of 2 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week |
| Treatment 5 mg/kg | Other | Drug: NPT189Five IV doses of 5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week |
| Treatment 12.5 mg/kg | Other | Drug: NPT189Five IV doses of 12.5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years, inclusive, at screening
- Weight 45-120 kg, inclusive
- Body Mass Index of 18.0-32.0 kg/m2, inclusive
- Female subjects of childbearing potential (defined as not surgically sterile or at least 2 years postmenopausal confirmed by a Screening Follicular Stimulating Hormone level of > 40) must agree to use two of the following forms of contraception from 60 days prior through 90 days following the dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, complete abstinence, or vasectomized partner (6 months minimum) or male subjects who are sexually active with women of childbearing potential must agree to complete abstinence or to use a condom for 90 days following the dose of study drug.
- No clinically significant abnormal findings on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory evaluation during screening; and systolic blood pressure between 140 mm and 90 mm Hg and diastolic blood pressure between 90 mm and 45 mm Hg.
Key exclusion criteria (9 listed)
- Have a past or present serious medical illness or other medical or social reason that in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Participation in a clinical trial (other than a screening visit) within 60 days of study drug administration.
- Use of any over-the-counter or prescription medication , vitamin preparations and other food supplements, or herbal medications (e.g., St. John's Wort) within 14 days prior to the dose of study drug or during the study, with the exception of hormonal contraceptives for women of childbearing potential, unless approved by the Principal Investigator or use of beta-blockers within 30 days prior to dose of study drug or during the study.
- Donation of blood or plasma within 30 days of the dose of study drug and throughout the duration of the study and for male subjects, donation of sperm through the duration of the study.
- Women who are nursing, pregnant, suspected of being pregnant, or trying to become pregnant, or are lactating, have a positive serum pregnancy test at screening or urine pregnancy test prior to administration of study drug regardless of childbearing potential.
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 |
|---|---|---|
| NPT189Also: IgG1 (Immunoglobulin G), Fusion Protein, GAIM (General Amyloid Interaction Motif)NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis. | Drug | Treatment 12.5 mg/kg, Treatment 2 mg/kg, Treatment 5 mg/kg |
Primary outcome
Adverse event assessment in subjects receiving multiple intravenous infusions of NPT189
Time frame: Day 1 through Day 112
Summary of the frequency and percentage of adverse events
6 secondary outcomes
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Cmax)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Tmax)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189 (AUC 0-tau)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189. Terminal elimination half-life (t 1/2)
Time frame: Day 1 through DAy 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Clearance (CL)
Time frame: Day 1 through Day 112
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Volume of distribution (Vd)
Time frame: Day 1 through Day 112
Results and safety
The study was stopped early (reason given: Mild infusion reactions were observed in two healthy volunteers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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.
Proclara Biosciences, Inc study director
Proclara Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NPT189 in people with Amyloidosis, run by Proclara Biosciences, Inc. at 1 site in Netherlands.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Aug 2019. 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 Netherlands. 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 was stopped early (reason given: Mild infusion reactions were observed in two healthy volunteers.). Results are not available in the source record.
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 assessment in subjects receiving multiple intravenous infusions of NPT189 (time frame: Day 1 through Day 112). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2019; AzTrials last refreshed its copy on 27 Oct 2026.