Clinical trials

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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 52
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Prime Gene Therapeutics Co., Ltd.Updated: Jun 2, 2026Locations: 1
Eligibility criteria

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

1. Participants with abnormal electrocardiogram results during screening (e.g.,...

Status: Not yet recruiting

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

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.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Prime Gene Therapeutics Co., Ltd.Updated: Jun 1, 2026Locations: 1
Eligibility criteria

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

1. Participants with clinically significant abnormal electrocardiogram results j...

Status: Not yet recruiting

A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see if PG-011 nasal spray works to treat moderate to severe seasonal allergic rhinitis

Participants needed: 600
Trial details
Phase: Phase 3Age: 18-65Biological sex: AllType: InterventionalSponsor: Prime Gene Therapeutics Co., Ltd.Updated: Aug 28, 2025Locations: 38
Eligibility criteria

Male or female aged 18 to 65 (including threshold). [+4]

Participants are diagnosed of active or latent tuberculosis infection. [+19]

Status: Recruiting

A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis

This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis. Participants will: * Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week. * Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week. * Keep a diary of their symptoms.

Participants needed: 472
Trial details
Phase: Phase 3Age: 12-75Biological sex: AllType: InterventionalSponsor: Prime Gene Therapeutics Co., Ltd.Updated: May 20, 2025Locations: 1
Eligibility criteria

12 years old≤ age ≤ 75 years old (including threshold), male or female. [+5]

Participant has unstable course of AD (spontaneously improving or rapidly deteri... [+13]