Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Pharmacokinetics (PK) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- DWRX2003
- Conditions
- Healthy
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 32
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is to assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of Niclosamide (DWRX2003) following escalating doses of DWRX2003 administered as an intramuscular injection in healthy volunteers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Normal healthy human adult male and female volunteers between 18-45 years (both ages inclusive) of age.
- •Volunteers who agree to give written informed consent and are willing to participate in the study.
- •Volunteer having bodyweight minimum of 50 kg.
- •Volunteer having Body Mass Index of 18.50 to 29.90 Kg/m2 (both inclusive).
Exclusion Criteria
- •Known allergic to Niclosamide or any component of the formulation and to any other related drug.
- •History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- •Female volunteers who are nursing mothers/lactating women or are found positive in beta hCG test.
- •History/ current use of Alcohol or drug abuse.
Arms & Interventions
cohort 1 (144 mg)
Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites
Intervention: DWRX2003
cohort 1 (144 mg)
Arms (both) 0.1 mL/site\*2 sites Hips (both) 0.2 mL/site\*2 sites
Intervention: Placebo
cohort 2 (432 mg)
Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites
Intervention: DWRX2003
cohort 2 (432 mg)
Arms (both) 0.3 mL/site \*2 sites Hips (both) 0.6 mL/site\*2 sites
Intervention: Placebo
cohort 3 (960 mg)
Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites
Intervention: DWRX2003
cohort 3 (960 mg)
Arms (both) 0.8 mL/site\*2 sites Hips (both) 1.2 mL/site\*2 sites
Intervention: Placebo
cohort 4 (1200 mg)
Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites
Intervention: DWRX2003
cohort 4 (1200 mg)
Arms (both) 1.0 mL/site \*2 sites Hips (both) 1.5 mL/site\*2 sites
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: follow-up 48 days after dosing
AE rate, incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Secondary Outcomes
- pharmacokinetic changes of niclosamide from baseline in each dose group: Cmax(follow-up 48 days after dosing)
- pharmcodynamic analysis of niclosamide from baseline in each dose group and time point: CRP(on Day 3, 7, 10 and 14)
- pharmacokinetic changes of niclosamide from baseline in each dose group: Tmax(follow-up 48 days after dosing)