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NCT07021157RecruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
First submitted
12 May 2025
Start date
9 Mar 2025
Primary completion date
7 Aug 2025
Lead sponsor
Consun Pharmaceutical Group
NCT number
NCT07021157

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 48
  • From 9 Mar 2025 to the primary completion date, 7 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Developed acute diseases from 2 weeks before screening to before randomization ;
  • Patients with previous or current hypotension or insufficient blood volume, intracranial hypertension or cerebral hemorrhage, or those with ocular diseases (such as angle-closure glaucoma), who are not suitable for inclusion after assessment by the researcher;
  • Those who have used any drugs or health supplements from 2 weeks before screening to randomization ;
  • Any drugs that may interact with this product have been used from 30 days before screening to randomization, such as CYP450 inhibitors or inducers ;
  • Those who have undergone major surgical operations from 6 months before screening , or who plan to undergo surgery during the study period, or who have undergone surgeries as judged by the investigator to affect drug absorption, distribution, metabolism, and excretion;
  • Those who have received live attenuated vaccine inoculation from 2 weeks before screening to randomization or those who need to receive live attenuated vaccine inoculation during the trial;
  • Those who smoked more than 5 cigarettes per day on average within 3 months before screening and before randomization, or were unable to stop using any tobacco products during the trial period;

Other illness

  • Have a specific history of allergies or have an allergic constitution;
  • Have a history of chronic diseases or severe diseases in the cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, mental, neuromuscular, gastrointestinal systems, etc.
  • Those who had a history of alcohol abuse within one year before screening;
  • Those who cannot tolerate venipuncture/indwelling needles or have a history of fainting from needles or blood ;

Other

  • Those with clinical significance hypokalemia, hyperkalemia, hypomagnesemia, hypermagnesemia, hypocalcemia, and hypercalcemia;
  • Other researchers determined that the subjects were not suitable to participate.

Who the study is looking for

  • Healthy male and female participants aged 18 to 45 years (inclusive).
  • Male participants: Body weight ≥50 kg; Female participants: Body weight ≥45 kg; Body mass index (BMI) between 19.0 and 26 kg/m².
  • Participants must have no plans for conception during the trial and for 3 months after the last dose, and must voluntarily use effective contraception with no plans for sperm or egg donation .
  • Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital, Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.