NCT02647281 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Han K, Cremer J, Elston R, Oliver S, Baptiste-Brown S, Chen S, Gardiner D, Davies M, Saunders J, Hamatake R, Losos J, Leivers M, Hood S, van der Berg F, Paff M, Ritter JM, Theodore D
A Randomized, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Mar 12. doi: 10.1002/cpdd.670. [Epub ahead of print]

A Double-Blind, Placebo-Controlled, Dose-Escalation, First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of GSK3389404 in Healthy Subjects

Details for clinical trial NCT02647281

Clinical trial NCT02647281 - References