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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06681389




Registration number
NCT06681389
Ethics application status
Date submitted
30/10/2024
Date registered
8/11/2024

Titles & IDs
Public title
A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis
Scientific title
A Randomized, Double-Blind Phase1b/2a Clinical Study to Evaluate Efficacy, Safety and Tolerability of Subcutaneous Administration of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis
Secondary ID [1] 0 0
NIB-IBD-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Adult Volunteers 0 0
Active Ulcerative Colitis 0 0
Active Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NP-201 acetate injection (Part A)
Treatment: Drugs - Placebo

Experimental: NP-201 Acetate Injection- Part A - 24 healthy participants across 3 cohorts will receive NP-201 acetate injection

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: NP-201 acetate injection (Part A)
Route of administration- Sub cutaneous. Dosage interval and frequency: MAD1-200mg daily for 5 days; MAD2- 300mg daily for 5 days, MAD3- 400mg daily for 5 days

Treatment: Drugs: Placebo
Matching placebo administered across Part A and Part B
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A-To evaluate the safety of NP-201 acetate injection by number of participants with AEs, SAEs and TEAEs
Timepoint [1] 0 0
Part A-Screening to Day 12 post first dose administration
Primary outcome [2] 0 0
Part A-Number of participants with abnormal laboratory values that are related to treatment
Timepoint [2] 0 0
Part A-Screening to Day 12 post first dose administration
Primary outcome [3] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- AUC from time 0 to 24 (AUC24)
Timepoint [3] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [4] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- AUC over the dosing interval (AUCtau)
Timepoint [4] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [5] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Area under curve from 0 to last AUC(0-last)
Timepoint [5] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [6] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Maximum plasma concentration at steadystate (Cmax,ss)
Timepoint [6] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [7] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- time to Cmax,ss (tmax,ss)
Timepoint [7] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [8] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Apparent oral body clearance at steady-state (CL/Fss)
Timepoint [8] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [9] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection- Apparent volume of distribution at steady-state (Vd/Fss)
Timepoint [9] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [10] 0 0
Part A-Plasma PK parameters following multiple doses of NP-201 acetate injection-Terminal half life (t1/2)
Timepoint [10] 0 0
Part A-Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Primary outcome [11] 0 0
Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- cumulative amount of drug excreted in urine (Ae)
Timepoint [11] 0 0
Part A-Samples collected on Day 1 and Day 5 post first dose administration
Primary outcome [12] 0 0
Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- percent fraction of drug recovered in urine (Fe)
Timepoint [12] 0 0
Part A-Samples collected on Day 1 and Day 5 post first dose adminstration
Primary outcome [13] 0 0
Part A-Urine PK parameters of NP-201 acetate injection after multiple doses- Renal clearance (CLr)
Timepoint [13] 0 0
Part A-Samples collected on Day 1 and Day 5 post first dose adminstration
Secondary outcome [1] 0 0
Part A- PK of NP-201 acetate injection metabolite- AUC from time 0 to 24 (AUC24)
Timepoint [1] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [2] 0 0
Part A- PK of NP-201 acetate injection metabolite- AUC over the dosing interval (AUCtau)
Timepoint [2] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [3] 0 0
Part A-PK of NP-201 acetate injection metabolite- Maximum plasma concentration at steady state (Cmax,ss)
Timepoint [3] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [4] 0 0
Part A- PK of NP-201 acetate Injection metabolite- Time to Cmax,ss (tmax,ss)
Timepoint [4] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [5] 0 0
Part A-PK of NP-201 acetate injection metabolite- Apparent oral body clearance at steady state (CL/Fss)
Timepoint [5] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [6] 0 0
Part A- PK of NP-201 acetate injection metabolite- Apparent volume of distribution at steady-state (Vd/Fss),
Timepoint [6] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration
Secondary outcome [7] 0 0
Part A-PK of NP-201 acetate Injection metabolite- terminal half-life (T1/2)
Timepoint [7] 0 0
Part A- Samples collected on Day 1, Day 2, Day 5 and Day 6 post first dose administration

Eligibility
Key inclusion criteria
1. Healthy males and females, between 18 to 60 years inclusive, at the time of Screening.
2. Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2(inclusive), at Screening, with a minimum body weight of 50 kg
3. In good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs measurement, and clinical laboratory evaluations at Screening, as assessed by the PI or designee.
4. All female participants of childbearing potential with male sexual partners and male participants with female sexual partners of childbearing potential must consent to use two highly effective methods of contraception from start of study and for at least 90 days (male and female participants) following the EOS visit or last dose of study treatment, whichever is later. Male participants must refrain from sperm donation from start of study and for 90 days after last dose of IP; female participants must refrain from donation of ova from start of study and for 30 days after last dose of IP. WOCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Screening, and be willing to undergo additional pregnancy tests, as required, throughout the study. Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months without an alternative medical cause), confirmed by follicle-stimulating hormone (FSH) level >40 IU/mL at Screening.
5. Participants whose smoking habit in the last 3 months prior to Screening included no more than 14 cigarettes per week (includes e-cigarettes and other nicotine and tobacco products) can be included in the study but must be willing to abstain from smoking from Screening until completion of the EOS visit (Part A only).
6. Ability and willingness to restrict the use of alcohol to = 21 units per week for males and = 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits. Participants must have negative alcohol breath tests at Screening and Day -1 visits.
7. Participants who are able to receive SC injections specifically participants who have scars or tattoos in the area of concern.
8. Participants must participate voluntarily, sign the ICF, have good compliance, be able and willing to attend the necessary site visits and be willing to cooperate with follow-up visits.
9. No history of severe allergic or anaphylactic reactions, including known allergies or hypersensitivities to NP-201 acetate or its excipients.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have a clinically significant medical history or surgical history and have at least one of the following findings:

1. Have skin diseases that may affect the absorption of the IP (eg, psoriasis, contact dermatitis), scars, tattoos, and skin abnormalities that may interfere with SC injections, or a history of surgery within 60 days of Screening (except for simple appendectomy or hernia repair, as assessed by the PI or designee).
2. Have a recent significant history of kidney diseases, pancreatitis and/ or nephrolithiasis.
3. Participants with liver cirrhosis accompanying edema and/or ascites.
4. Have known clinically significant allergies as assessed by the PI or designee, diseases of either/or the cardiovascular system, peripheral vascular system, skin, mucous membranes, eyes, respiratory system, musculoskeletal system, and/or any other diseases that may pose a problem with the PK evaluation. History of childhood asthma can be included at the discretion of the PI or designee.
5. Presence of any underlying physical, or psychological medical condition that, in the opinion of the PI or designee, will make it unlikely that the participant will comply with the protocol, or complete the study per the protocol.
2. Pregnant or lactating at Screening or planning to become pregnant at any time during the study, including the follow-up period.
3. Have a clinically relevant history of hypersensitivity reactions or allergic reactions to drugs (such as aspirin and antibiotics), or known drug allergies (eg, to aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], antibiotics, iodine, anesthetics, other monoclonal antibodies, etc.).
4. Participants who have donated whole blood within 60 days prior to Screening or blood components within 30 days or received blood transfusion within 60 days.
5. Have received an IP or bioequivalence IP in another clinical study or bioequivalence study within 30 days prior to Screening or five half-lives prior to Screening.
6. Use of any prescription drugs within 14 days prior to dosing or non-prescription medications/products, including vitamins, minerals, and phyto-therapeutic/herbal/plant-derived preparations, alternative medicines, or dietary supplements within 7days prior to dosing (at the discretion of the PI or designee). The occasional use of paracetamol(up to 2g/day) is permitted.
7. History of alcoholism, substance or drug abuse-related disorders deemed significant by the PI or designee.
8. Participants with a positive toxicology screening panel. Positive test may be repeated once at the discretion of the investigator.
9. Have positive serology test (hepatitis B surface antigen [HBsAg], or hepatitis C virus antibody [anti-HCV], human immunodeficiency virus [HIV] test,) at Screening.
10. Active infection requiring medical treatment and/or isolation at the time of Screening.
11. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) > 2.0 × upper limit of normal (ULN).
12. Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
13. QTcF > 450 msec for male participants or QTcF > 470 msec for female participants. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF).
14. Participants with corrected calcium (Ca) > ULN, uric acid > ULN, and/or estimated glomerular filtration rate < 90 mL/min, calculated using Cockroft Gault formula.
15. Others who are ineligible to participate in this clinical study as determined by the PI or designee.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
25/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NIBEC Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michele DeSciscio, Dr.
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michele DeSciscio, Dr.
Address 0 0
Country 0 0
Phone 0 0
+61 870887900
Fax 0 0
Email 0 0
cmax@cmax.com.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06681389