None listed
Conditions
Brief summary
This is a first-in-human (FIH) study to assess the safety, tolerability and pharmacokinetics of single-dose study of NP-201 acetate injection in healthy volunteers, Approximately 32 participants (8 participants per dose group) will be randomized across 4 sequential treatment dose groups. Participants will be randomized to receive either the NP-201 acetate or the placebo in a ratio of 6:2 (6 participants will receive the IP and 2 participants will receive the placebo). The study consists of screening (Day - 35 to Day -2), Baseline (Day -1), end of study visit (Day 29). Oversight of the study will be provided by a safety monitoring committee (SMC) comprising of the PI, local Medical Monitor (MM), and the Sponsor’s MM.
Interventions
Investigational Product (IP): NP-201 acetate injection
Route of Administration: subcutaneous injection
Dosage and frequency:
Dosing group 1: 100 mg of NP-201 acetate administered once on Day 1
Dosing group 2: 200 mg of NP-201 acetate administered once on Day 1
Dosing group 3: 300 mg of NP-201 acetate administered once on Day 1
Dosing group 4: 400 mg of NP-201 acetate administered once on Day 1
The participants will be randomized across 4 sequential treatment dose groups to receive either the NP
Investigational Product (IP): NP-201 acetate injection Route of Administration: subcutaneous injection Dosage and frequency: Dosing group 1: 100 mg of NP-201 acetate administered once on Day 1 Dosing group 2: 200 mg of NP-201 acetate administered once on Day 1 Dosing group 3: 300 mg of NP-201 acetate administered once on Day 1 Dosing group 4: 400 mg of NP-201 acetate administered once on Day 1 The participants will be randomized across 4 sequential treatment dose groups to receive either the NP-201 acetate or the placebo in each dosing group. There is total 4 dosing group. Each dose group will enrol 8 participants and will be divided into 2 blocks to implement the sentinel dosing approach. The first block in each dose group consists of 2 sentinel participants; 1 participant will receive NP-201 acetate and the other will receive the placebo-to-match. The second block will consist of the remaining 6 participants, who will be randomized to receive either NP-201 acetate (n = 5) or the placebo-to-match (n = 1). The participants are required to fast for at least 10 hours and restrict the intake of water for 1 hour prior to administration. The IP will be administered by appropriately trained study staff under the supervision of Investigator. The dose administered, and the time of administration (time of start of the injection) will be checked and recorded. Each dosing group will enrol distinct group of participants. Dosing groups will begin after safety assessment of the previous cohort has been completed, all dosing groups will run one after the other.
Sponsors
NIBEC Co., Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 kg/m2 and less than 32 kg/m2 at Screening, with a minimum body weight of 50 kg and a maximum body weight of 100 kg (inclusive). 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) 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. 5) Participants who are able to receive SC injections. 6) All female participants of childbearing potential with male partners and male participants with female partners of childbearing potential must consent to use 2 highly effective methods of contraception from start of study and for at least 90 days following the EOS visit or last dose of study treatment, whichever is later. WOCBP on hormonal contraceptives must be stable on the medication for at least 2 menstrual cycles prior to Day -1. The following are acceptable methods of highly effective contraception: a. Using twice the normal protection of birth control by using a condom AND one other form of contraception; either birth control pills (The Pill), or injectable birth control, birth control patch or contraceptive implant associated with inhibition of ovulation, or intrauterine device; or b. Surgical sterilization as a single form of birth control: i.e., tubal ligation, hysterectomy, bilateral oophorectomy, vasectomy, or equivalently effective surgical form of birth control (with documented proof of the absence of sperm in the post-vasectomy ejaculate) at least 6 months prior to Screening; or c. True sexual abstinence for the duration of the study and for at least 12 weeks following the EOS visit or after the last dose of IP, whichever is later, is acceptable only when in line with the preferred and usual lifestyle of the participant. Periodic abstinence (calendar, symptothermal, post ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea methods are not considered “true” abstinence and are not acceptable methods of contraception. 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 120 days after last dose of IP. WOCBP must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1, and be willing to undergo additional pregnancy tests, as required, throughout the study. If a participant’s pregnancy test is positive, they will be referred to their primary care provider for follow up; they will not be enrolled in 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 greater than 40 IU/mL at Screening. Female or male participants who are exclusively in same-sex relationships as their preferred and usual lifestyle are not required to use contraception. 7) Ability and willingness to restrict the use of alcohol to equal to 21 units per week for males and equal to 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. 8) Participants must participate voluntarily, sign the informed consent form (ICF), have good compliance, be able and willing to attend the necessary site visits and be willing to cooperate with follow-up visits. 9) Participants must refrain from intensive exercise during the study. 10) Participants should be fully vaccinated (3 doses of an approved vaccine) against SARS CoV 2 at least 2 weeks prior to the Screening visit.
Exclusion criteria
1) Have a clinically significant medical history or surgical history and have at least 1 of the following findings: a) Have skin diseases that may affect the absorption of the IP (eg, psoriasis, contact dermatitis), scars 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). b) Have a recent significant history of kidney diseases, pancreatitis and/ or urinary stones. c) Have a recent significant history of lung diseases and/or asthma or pneumonia. d) Have tested positive during Screening for SARS-CoV-2 viral infection. e) 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 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. 2) Pregnant or lactating at Screening or planning to become pregnant at any time during the study, including the follow-up period. 3) Have history of bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). 4) Have a history of hypersensitivity reactions or allergic reactions to drugs containing NP 201 or ingredients in the same class, or other drugs (such as aspirin and antibiotics), or known drug allergies (e.g., to aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], antibiotics, iodine, anesthetics, other monoclonal antibodies, etc.). 5) 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. 6) 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. 7) Use of any prescription drugs or non-prescription medications/products, including vitamins, minerals, and phyto-therapeutic/herbal/plant-derived preparations, oriental medicines, or dietary supplements within 14 days prior to Screening or over-the-counter drugs within 7 days. The occasional use of paracetamol (up to 2g/day) is permitted. 8) History of alcoholism, substance or drug abuse-related disorders deemed significant by the PI or designee. 9) Participants with a positive toxicology screening panel (urine test including qualitative identification of barbiturates, morphine, cocaine, tetrahydrocannabinol [THC], amphetamines and methamphetamines, benzodiazepines, tricyclic antidepressants [TCAs], methadone, and phencyclidine). 10) Have positive serology test (hepatitis B surface antigen [HBsAg], or hepatitis C virus antibody [anti-HCV], human immunodeficiency virus [HIV] test, syphilis test) at Screening. 11) Active infection requiring medical treatment and/or isolation. 12) Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) more than 2.0 × upper limit of normal (ULN). 13) Bilirubin more than 1.5 × ULN (isolated bilirubin greater than 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35 percentage). 14) QTc more than 450 msec for male participants or QTc more than 470 msec for female participants. The QTc is the QT interval corrected for heart rate according to Fridericia’s formula (QTcF). 15) Participants with greater than ULN of calcium (Ca), uric acid, and/or less than or equal to lower limit of normal (LLN) of less than 90 mL/min calculated using Cockroft and Gault formula. 16) 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. 17) Participants with tattoos, scars, and/or sites with bruises and redness that cover the abdomen. 18) Others who are ineligible to participate in this clinical study as determined by the PI or designee.
Outcome results
None listed