None listed
Conditions
Interventions
Intervention1: DWRX2003: Niclosamide IM depot Injection 240mg/1ml of Daewoong Pharmaceutical (India)
Pvt. Ltd.
Intervention2: Niclosamide IM depot Injection 960 mg/4 ml: Niclosamide IM depot Injection
Sponsors
Daewoong Pharmaceutical India Pvt Ltd
Mankind Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age. 2. Volunteers who agree to give written informed consent and are willing to participate in the study. 3. Volunteer having bodyweight minimum of 50 kg. 4. Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive). 5. No evidence of underlying disease during the pre-study screening, medical history, physical examination and laboratory investigations done within 21 days prior to commencement of the study. 6. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. 7. Volunteer who are non-smoker, non-tobacco (in any form) users; non-alcoholic with negative test for alcohol, Negative urine drug of abuse test (Tetrahydrocannabinol (THC), Opiates, Cocaine, Barbiturates, Amphetamine and Benzodiazepines). 8. Volunteer who is negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C, and RPR. 9. Volunteer with 12 lead ECG recording within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his/her participation in the study. 10. Chest X-ray taken within 06 months before the day of dosing, which is considered as normal or clinically insignificant as per Investigator discretion. 11. Volunteer who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. 12. Female volunteers who are having negative results in urine pregnancy test during screening and Beta hCG-test at the time of check-in. 13. Female volunteers of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment (Preferably two methods). 14. Male volunteers and/or Female volunteerâ??s partner must agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 30 days after dosing of study treatment (Preferably two methods).
Exclusion criteria
Exclusion criteria: 1. Known allergic to Niclosamide or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease. 3. Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test. 4. History/ current use of Alcohol or drug abuse. 5. History/ current smoker or tobacco (in any form) user. 6. Asthma, urticaria or other allergic type reactions after taking any medication. 7. Clinically significant illness within 4 weeks before the start of the study. 8. History of clinically relevant allergy (except for untreated, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 9. History of vascular collapse. 10. Volunteer who is scheduled for surgery any time during study or within 30 days after dosing of study treatment (Preferably two methods). 11. History of difficulty in donating blood. 12. Volunteer who is participating in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 13. Volunteer who has taken prescription medication or over-the-counter products (including vitamins and products from natural origin e.g. St. Johnâ??s Wort) within 14 days prior to administration of study medication, including topical medication meant for systemic absorption. 14. Volunteer who was hospitalized within 28 days prior to administration of the study medication. 15. Volunteer who has unsuitable veins for repeated vein puncture. 16. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 17. Volunteer who has Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 18. Volunteer who has Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of Niclosamide IM depot Injection 960mg/4ml (DWRX2003) following escalating doses of DWRX2003 administered as intramuscular injection in healthy volunteers.Timepoint: Pre-dose sample (00.00hour) 02.00 hours before dosing. Post-dose samples at 00.25, 00.50, 00.75, 01.00, 01.25, 01.50, 02.00, 03.00, 04.00, 06.00, 08.00, 10.00, 12.00, 24.00 (Day 2), 48.00 (Day 3), 96.00 (Day 5), 144.00 (Day 7),216.00 (Day 10), 312.00 (Day 14), 480.00 (Day 21) and 648.00 (Day 28) hours after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Niclosamide IM depot Injection 960mg/4ml (DWRX2003) following escalating doses of DWRX2003 administered as intramuscular injection in healthy volunteersTimepoint: blood pressure, pulse rate, respiratory rate and temperature measurement (either by oral or axillary or by infrared thermometer) and Wellbeing will be assessed after dosing at 01.00, 03.00, 06.00, 09.00, 13.00, 24.00, 36.00, 48.00, 60.00, 72.00 and 84.00 hours post-dose of the study. ECG recording will be done before check-in and after dosing at 01.00 (± 30 minutes) hour, on Day 3, 7, 10, 14 and 28 of the study. | — |
Countries
India
Contacts
Public ContactLakshmikanth Maddela
Ecron Acunova Limited
Outcome results
None listed