A Study of NPT189 in Healthy Subjects

NCT03610035 | Completed Phase 1 DMC

• 1 other identifier: NPT189-CL001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single dose of NPT189 in healthy volunteers. The study will also evaluate the pharmacokinetic characteristics of NPT189.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Safety of a single intravenous (IV) infusion of NPT189 (subjects experiencing adverse events)

  Summary of the frequency and percentage of

  Day 1 through to Day 49

Secondary Outcomes (7)

• Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (Cmax)

  Day 1 through to Day 49

• Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (Tmax)

  Day 1 through to Day 49

• Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (AUClast)

  Day 1 through to Day 49

• Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189 (AUCinf)

  Day 1 through to Day 49

• Profile of pharmacokinetics (PK) of a single intravenous (IV) infusion of NPT189. Terminal elimination half-life (t 1/2)

  Day 1 through to Day 49

Study Arms (2)

Experimental

EXPERIMENTAL

NPT189

Drug: NPT189

Placebo Comparator

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NPT189 DRUG

IgG1 Fc-GAIM fusion protein, a recombinant fusion protein

Also known as: IgG1 (Immunoglobulin G), Fusion Protein, GAIM (General Amyloid Interaction Motif)

Experimental

Placebo DRUG

Placebo

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between the ages of 18 and 65 years (inclusive);
• Has provided written informed consent to participate in the study;
• Weigh ≥ 45kg and ≤ 120kg with Body Mass Index of 18-32 inclusive;

You may not qualify if:

• Female subjects of childbearing potential (defined as not surgically sterile or at least two years postmenopausal confirmed by a Screening Follicle Stimulating Hormone (FSH) level of \> 40) must agree to use one 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), intrauterine device (IUD), complete abstinence, or vasectomized partner (6 months minimum) or male subjects who are sexually active with women of child-bearing 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, 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.
• 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 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 (Day -1 only) or, drugs of abuse, or cotinine at Screening and on Day -1;
• Have clinically significant abnormalities in laboratory values as judged by the clinical investigator;
• Have a history of alcoholism and/or drug abuse;

Sponsors & Collaborators

• Proclara Biosciences, Inc.: lead

Study Sites (1)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• Krishnan R, Tsubery H, Proschitsky MY, Asp E, Lulu M, Gilead S, Gartner M, Waltho JP, Davis PJ, Hounslow AM, Kirschner DA, Inouye H, Myszka DG, Wright J, Solomon B, Fisher RA. A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies. J Mol Biol. 2014 Jun 26;426(13):2500-19. doi: 10.1016/j.jmb.2014.04.015. Epub 2014 Apr 22.

  PMID: 24768993 BACKGROUND

MeSH Terms

Conditions

Amyloidosis

Interventions

Immunoglobulin G

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Proclara Biosciences

  Proclara

  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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 1, 2018
• Study Start: July 24, 2018
• Primary Completion: February 17, 2019
• Study Completion: February 17, 2019
• Last Updated: August 15, 2019

Record last verified: 2018-12

Locations

NL (1)