- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879278
Multiple Ascending Dose Study in Healthy Subjects
August 14, 2019 updated by: Proclara Biosciences, Inc.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9728 NZ
- PRA Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Treatment 2 mg/kg
Five IV doses of 2 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week
|
NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
Other Names:
|
OTHER: Treatment 5 mg/kg
Five IV doses of 5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week
|
NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
Other Names:
|
OTHER: Treatment 12.5 mg/kg
Five IV doses of 12.5 mg/kg NPT189 (n = 6) or matching placebo (n = 2) administered once per week
|
NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1 through Day 112
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Cmax)
Time Frame: Day 1 through Day 112
|
Observed maximum concentration (Cmax)
|
Day 1 through Day 112
|
Profile of pharmacokinetics (PK) of multiple intravenous (IV) infusions of NPT189 (Tmax)
Time Frame: Day 1 through Day 112
|
Time of the maximum measured concentration (Tmax)
|
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
|
Area under the serum concentration-time curve over a dosing interval, tau
|
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
|
Terminal elimination half-life (t 1/2)
|
Day 1 through DAy 112
|
Profile of pharmacokinetics (PK) of multiple (IV) infusions of NPT189. Clearance (CL)
Time Frame: Day 1 through Day 112
|
Clearance (CL)
|
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
|
Apparent volume of distribution (Vd)
|
Day 1 through Day 112
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Proclara Biosciences, Inc, Proclara Biosciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 6, 2019
Primary Completion (ACTUAL)
June 27, 2019
Study Completion (ACTUAL)
June 27, 2019
Study Registration Dates
First Submitted
March 12, 2019
First Submitted That Met QC Criteria
March 15, 2019
First Posted (ACTUAL)
March 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPT189-CL002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyloidosis
-
Millennium Pharmaceuticals, Inc.CompletedLight-Chain AmyloidosisUnited States, Canada, France, Germany, Italy
-
Boston UniversityCorino Therapeutics, Inc.CompletedTransthyretin Amyloidosis | Amyloidosis, Leptomeningeal, Transthyretin-RelatedUnited States
-
Chulalongkorn UniversityUnknown
-
Criterium, Inc.AmgenCompletedAmyloidosis | Systemic Light Chain AmyloidosisUnited States
-
Steen Hvitfeldt PoulsenRecruitingTransthyretin Amyloidosis | Transthyretin Cardiac Amyloidosis | Wild-Type Transthyretin-Related (ATTR)AmyloidosisDenmark
-
IRCCS Policlinico S. MatteoRecruiting
-
University Hospital Center of MartiniqueTerminated
-
Peking Union Medical College HospitalXian-Janssen Pharmaceutical Ltd.Active, not recruitingAmyloidosis; SystemicChina
-
Kaneka Medical America LLCRecruitingDialysis AmyloidosisUnited States
-
Peking Union Medical College HospitalRecruitingLight Chain (AL) Amyloidosis | Venetoclax | CCND1 TranslocationChina