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RECRUITING
NCT07021157
PHASE1

A Study to Evaluate the Safety, Tolerability and PK of SK-08

Sponsor: Consun Pharmaceutical Group

View on ClinicalTrials.gov

Summary

The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.

Official title: A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single-dose Increasing of SK-08 Tablets in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-03-09

Completion Date

2025-08-07

Last Updated

2025-06-24

Healthy Volunteers

Yes

Interventions

DRUG

SK-08

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given SK-08 once.

DRUG

Placebo

Dose groups of 5 mg, 7.5mg,12.5 mg, 30 mg, 45 mg, and 60 mg were given placebo once.

Locations (1)

The First Affiliated Hospital,Zhejiang University

Hangzhou, Zhejiang, China