Pharmacokinetics of PN-232 in Healthy Volunteers

Protagonist Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: PN-232; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04819620

PN-232-01

Details and patient eligibility

About

This Phase 1 study is designed to determine the safety, tolerability and pharmacokinetics of PN-232 in healthy volunteers. It is a first-in-human (FIH) study for PN-232 that will be conducted in three parts. Part 1 is a single ascending dose study, Part 2 is multiple ascending dose study, and Part 3 is crossover solid dose comparison and effect of food study.

Full description

Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.

Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.

Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.

In total, approximately 84 subjects will participate.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects must have BMI between 18 and 32 kg/m2
• Subjects must be non-smokers or social smokers
• Subjects must comply with contraception requirements
• Subjects must be willing to consume meals provided by the clinical center
• Subjects must be willing to attend required clinic visits
• Subjects must be suitable candidates for study procedures

Key Exclusion Criteria:

• Subject with a history of clinically significant endocrine, neurological, cardiovascular, hematological, hepatic, immunological, renal, respiratory, gastrointestinal or genitourinary abnormalities or diseases within previous 10 years
• Subjects with a history of surgical resection of the stomach, small or large intestine
• Subjects with a fever or symptomatic viral or bacterial infection within 2 weeks of screening or intestinal infection within 30 days prior to screening
• Subjects with clinically significant laboratory abnormalities
• Subjects with corrected QT greater than 450 msec in males and 470 msec in females
• Subjects who test positive for Hepatitis C or B, or HIV at Screening
• Subjects who cannot refrain from use of prescription and non-prescription drugs and herbal remedies prior to initial dose of study drug and throughout the study
• Subjects who test positive for drugs of abuse or alcohol at Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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48 participants in 3 patient groups

Single Dose

Experimental group

Description:

Single dose administration

Treatment:

Drug: Placebo

Drug: PN-232

Multiple Dose

Experimental group

Description:

Multiple dose administration

Treatment:

Drug: Placebo

Drug: PN-232

Solid Dose Comparison

Experimental group

Description:

Solid dose administration

Treatment:

Drug: PN-232