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drugset / Trial / NCT06350279

A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects

NCT06350279 ↗

Phase 1 Completed 96 enrolled Haisco Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupDouble-blindOther

Summary

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.

Timeline

Start
2023-12-25
Primary completion
2024-08-02
Completion
2024-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject HSK39297 Unknown — Oral

Indications

No indication recorded.