Clinical Research Directory

Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar With That From Clexane

An Open-Label, Single-center, Randomized, Single-Dose, Two-Way Crossover Biosimilarity Study to Determine the Comparative Pharmacodynamics of Enoxaparin Sodium Biosimilar 40mg/0.4ml with that from the Reference IMP, Clexane® (40 mg/0.4ml), Following Single-Dose Administration in Healthy Participants. Test: Enoxaparin Sodium (Enoxaparin Sodium 40mg/0.4ml) manufactured by EIPICO, Egypt. Reference: Clexane (Enoxaparin Sodium 40mg/0.4ml) manufactured by Sanofi Aventis, Egypt. Primary objective: To assess biosimilarity between a single dose from the test product versus the reference product in healthy participants Secondary objective: To investigate the safety and tolerability of the formulations. This study is a randomized single-dose, two-way, two-period, two-sequence, crossover biosimilarity study with a washout period of one week after each dosing.A minimum of 21 healthy adult male and female participants from Egyptian population will be enrolled in this study, along with 5 additional participants to account for potential dropouts or withdrawal. 26 Participants plus 1-4 alternates will be admitted to the study. An alternate participant will be dosed by the same sequence as the withdrawn participant only if any participant of the first 26 Participants withdraws before the first study drug administration. Withdrawals after study drug administration will not be replaced. All participants will be healthy adults aged (21-55) years, with a BMI within the accepted range of 18.5-30 kg/m², and will meet the study's selection criteria.

Study of BW-50218 in Healthy Participants

Phase 1, Single Ascending Dose Study of Subcutaneous BW-50218 in Healthy Participants

Positive Psychology - Based EMl for Enhancing Well-Being

This study aims to evaluate the acceptability and effectiveness of a positive psychology-based ecological momentary intervention (EMI) for enhancing well-being in college students. A three-arm randomized controlled trial (RCT) will assess the impact of a dynamic EMI that delivers personalized exercises when participants' real-time affect or well-being scores fall below a predefined threshold, compared to control conditions. Primary outcomes include changes in well-being and mental health, evaluated through a mixed-methods approach combining quantitative measures and qualitative interviews.

To Evaluate the Effect of Bacillus Subtilis Based Product in Gut Health and Immunomodulatory Effect in Healthy Adults.

The goal of this clinical trial is to Assess Gut Health and Immunomodulatory Effects of Bacillus Subtilis based product in Healthy Adults The main question\[s\] it aims to answer are to assess the effects of Bacillus Subtilis on gut health in healthy adults by measuring changes in fecal calprotectin levels as a marker of intestinal inflammation, in comparison between the intervention and placebo group. To assess the immunomodulatory effects of Bacillus-Subtilis by measuring changes in inflammatory and immune response markers, in comparison between the intervention and placebo group To confirm the safety and tolerability of the study product Bacillus Subtilis in the healthy study population during the intended use, with safety assessments conducted across both the intervention and placebo groups. The primary and secondary outcomes are: Primary Efficacy Outcome: * Change in fecal calprotectin levels from baseline to the end of the study, comparing the intervention and placebo groups. * Changes in immunological markers (IgA, IgG, IgM) between baseline and study completion, comparing the intervention and placebo groups. Secondary Efficacy Outcome: • Improvement in the patient related overall relief, assessed using Gut Health Status Questionnaire (GHSQ) and Immune status questionnaire (ISQ) score with comparative analysis between the two groups. Participants will be asked to take the probiotics twice daily morning and evening after meals and record it in the subject diary.

Assessment of the Relationship of Soft Contact Lens Fit and Power (Fit & Lens pOwer Soft lenSes)

The purpose of this study is to evaluate whether altering the optical power (in dioptres) of a contact lens affects both vision and lens fit. As the majority of modern contact lens wearers prefer daily disposable soft lenses, the trial lenses used in this study-provided by CooperVision-reflect this trend, representing nearly 80% of the current UK market. This study aims to generate data supporting the use of contact lenses with powers that do not precisely match a participant's visual prescription (within ±2.00 dioptres) as a viable temporary alternative when the exact required power is unavailable. At present, there is no published literature in the context of modern contact lens design that compares the fitting characteristics of 'fit-for-purpose' lenses with those of lenses from the same design family that would not typically be selected due to power mismatch.

Absolute Bioavailability Study of Cizutamig in Healthy Adult Participants

The purpose of this study is to determine the absolute bioavailability of SC administered cizutamig in healthy adult participants.

Impact of Digital Oral Health Educational Program on a Group of Geriatrics Oral Health and Quality of Life Compared to Standard Oral Health Educational Program in Egypt

The aim of the study is to evaluate the impact of a digital oral health education program on the oral health status and quality of life for geriatric populations compared to standard oral health education in Egypt.

ACT-based EMI in College Students

This study aims to evaluate the acceptability and effectiveness of a transdiagnostic, Acceptance and Commitment Therapy (ACT)-based ecological momentary intervention (EMI) among college students. A mixed-methods pilot randomized controlled trial (RCT) will be conducted to assess its impact on psychological flexibility, well-being and mental health outcomes.

Phase 1 Study of PRX019 in Healthy Adult Volunteers

The purpose of this study is to assess the safety and tolerability of PRX019 in healthy adult participants.