ReacX Pharmaceuticals, Inc.
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks. Additionally the pharmacokinetics (PK), how fast the drug is absorbed into the body and how long it remains in the body, will also be studies. The data collected in this healthy volunteer study will inform the Sponsor on how best to proceed with future trials in the intended patient population.
This is a single center, Phase 1, open-label, safety, tolerability, and PK study designed to compare one (1) or two (2) nalmefene implants in healthy subjects. The study will include a screening period from Day -28 to Day -2, where subjects will be evaluated according to the Inclusion/Exclusion Criteria. Enrollment will be initially restricted to Cohort 1 (1 implant) until the Safety Review Committee (SRC) completes an evaluation of the safety data, of at least 5 subjects, through the Week 4 Visit. The SRC will then advise the Sponsor as to whether to open enrollment to Cohort 2 (2 implants).…
Inclusion Criteria: \- Subjects must meet all of the following criteria to be included in the study: 1. Male or female, non-smoker, ≥18 and ≤55 years of age, with body mass index (BMI) \>18.5 and \<35.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females. 2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to implant insertion. 2. the absence of clinically significant history of dermatologic, neurological, musculoskeletal, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointes…
One implant
Two Implants
Arctuva estimate
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