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A Study to Evaluate the Multiple Dose Ascending of PG-033 in Healthy Adult Participants.

ConditionLichen Simplex Chronicus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPrime Gene Therapeutics Co., Ltd.

About this trial

The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of multiple ascending oral doses(MAD) of PG-033 by directly comparing it with placebo.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1. Read, understood, and signed an ICF before any investigational procedure(s) are performed..

Disqualifiers

1. Participants with clinically significant abnormal electrocardiogram results judged by the investigator during screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PG-033 tablets

    Drug

    Oral tablets (2mg, 10mg)

  • PG-033 placebo comparator

    Drug

    Oral tablets (2mg, 10mg) (matching corresponding study medication)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Multiple Ascending Doses of PG-033 tabletsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of PG-033 tablets

Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)

Time frame
17 days

Secondary outcomes

1

Pharmacokinetics-Cmax

Maximum Observed Plasma concentration (Cmax)

Time frame
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
2

Pharmacokinetics-Tmax

Time at which the maximum plasma concentration (Cmax) occurs

Time frame
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
3

Pharmacokinetics-AUC0-t

Area under the plasma concentration-time curve from dosing (time zero） to the time of the last measured concentration

Time frame
D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
4

Pharmacokinetics-AUC0-∞

Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞）

Time frame
1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose

Other outcomes

Sponsors and contacts

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

Prime Gene Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: