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Placebo - 0.9% w/v sodium chloride solution
0.9% sodium chloride solution is an isotonic saline that serves as a physiologically inert vehicle for drug delivery or as a control comparator in clinical trials.
0.9% sodium chloride solution is an isotonic saline that serves as a physiologically inert vehicle for drug delivery or as a control comparator in clinical trials. Used for Placebo control in Phase 3 clinical trials.
At a glance
| Generic name | Placebo - 0.9% w/v sodium chloride solution |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Normal saline (0.9% w/v NaCl) is a sterile solution with osmolarity matching human blood plasma, making it suitable for intravenous, intramuscular, or topical administration without causing cellular damage. In Phase 3 trials, it is typically used as a placebo control to establish the efficacy of an investigational therapeutic agent by comparison against an inert standard.
Approved indications
- Placebo control in Phase 3 clinical trials
Common side effects
- Injection site reactions (if administered parenterally)
- Hypernatremia (with excessive or prolonged use)
- Fluid overload (with large volume administration)
Key clinical trials
- Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection (PHASE1)
- TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study (PHASE4)
- Preoperative Skin Preparation Evaluation (PHASE3)
- Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections (PHASE3)
- Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants (PHASE1)
- A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects (PHASE1)
- A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body (PHASE1)
- PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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