A Phase I Clinical Trial to Evaluate the Single Dose Ascending and Food Effects of PG-033 in Healthy Adults

Trial statusRecruiting
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 single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body,as well as investigate the effect of PG-033 on the QTc interval.

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 abnormal electrocardiogram results during screening (e.g., QT/QTcF > 440 ms, PR interval > 200 ms, QRS complex duration > 100 ms, clinically significant abnormalities of the P wave, clinically significant changes in the ST-T wave, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • PG-033

    Drug

    Oral tablets (2mg, 10mg)

  • PG-033 placebo comparator

    Drug

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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Single 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
Single Ascending Dose study: 7 days;Food Effect study: 14 days

Secondary outcomes

1

Pharmacokinetics parameter: Cmax

Maximum Observed Plasma concentration (Cmax)

Time frame
up to 3 days
2

Pharmacokinetics Parameter:Tmax

Time at which the maximum plasma concentration (Cmax) occurs

Time frame
up to 3 days
3

Pharmacokinetics parameter: AUC0-t

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

Time frame
up to 3 days
4

Pharmacokinetics parameter: AUC0-∞

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

Time frame
up to 3 days

Other outcomes

Sponsors and contacts

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