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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects

StatusEnrolling by Invitation
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 17, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Primary completion pushed from Jul 1, 2026 to Oct 1, 2026
    • Study completion pushed from Sep 1, 2026 to Dec 1, 2026
    • Interventions: F-02-2-Na Matching Placebo (0.5mg) (Drug), F-02-2-Na Matching Placebo (100mg) -Multiple dose (Drug), F-02-2-Na Matching Placebo (150 mg)… to F-02-2-Na Matching Placebo (0.5 mg) (Drug), F-02-2-Na Matching Placebo (10 mg) (Drug), F-02-2-Na Matching Placebo (100 mg) -Multiple dose…
    • Study description expanded, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple orally administered doses of F-02-2-Na in adult subjects with Hyperuricemia.
Trial Details
NCT Number NCT07324434
Lead Sponsor Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Collaborators: Xiangbei Welman Pharmaceutical Co., Ltd, Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.
Conditions
(from sponsor)
Hyperuricemia With or Without Gout
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov