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A Study to Evaluate the Safety, Tolerability and PK of SK-09

ConditionsFSGSMCD
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorConsun Pharmaceutical Group

About this trial

This Phase 1 trial consists of three parts: Part 1 is a Single Ascending Dose (SAD) study, Part 2 is a Multiple Ascending Dose (MAD) study. Both parts adopt a randomized, double-blind, placebo-controlled design. Part 3 is a randomized, open-label, single-dose, two-period crossover self-controlled design FE study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male and female participants aged 18 to 55 years (inclusive) at the time of screening.

Participants must be in good general health.

Capable of understanding and voluntarily providing written informed consent prior to any study-related procedures.

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 .

Disqualifiers

History or current presence of clinically significant Cardiovascular; Respiratory ; Gastrointestinal; Neurological ; Hematologic/immunologic disorders.

Chronic GI conditions requiring daily medication; or history of bariatric surgery.

Live/attenuated vaccines within 4 weeks prior to dosing or planned during study.

Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure ≥80 mmHg.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SK-09

    Drug

    SAD:Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given. MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) will be given. FE：Dose group (150mg) was given.

  • Placebo

    Drug

    SAD：Dose groups of 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg were given. MAD：Dose groups (low100 mg BID, 200 mg BID, and 500mg QD or 300mg BID/medium/high, based on Part 1 SAD results) were given.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: SK-09Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety Evaluation

Number of participants with AE, with abnormal Vital Signs, abnormal Physical Examination findings, abnormal Laboratory Tests results, abnormal 12-lead ECG readings

Time frame
up to 8 days post-dosing for SAD ，up to 14 days post-dosing for MAD， up to 14 days first post-dosing for FE.

Secondary outcomes

1

PK Evaluation（Cmax）

Pharmacokinetic characteristics after administration (Cmax）

Time frame
up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
2

PK Evaluation（Tmax）

Pharmacokinetic characteristics after administration

Time frame
up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
3

PK Evaluation（ AUC0-T）

Pharmacokinetic characteristics after administration (AUC0-T）

Time frame
up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD
4

PK Evaluation ( AUC0-∞）

Pharmacokinetic characteristics after administration ( AUC0-∞）

Time frame
up to 72 hours post-dosing for SAD and FE，up to 10 days post-dosing for MAD

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consun Pharmaceutical Group

Lead sponsor

Source ClinicalTrials.gov
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