Safety and Tolerability of GX-P1 in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2021-06-07

Brief Summary

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This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1

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Detailed Description

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Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GX-P1 dose level 1

Group Type EXPERIMENTAL

GX-P1 or Placebo (dose level 1)

Intervention Type DRUG

GX-P1 dose level 1 or placebo

GX-P1 dose level 2

Group Type EXPERIMENTAL

GX-P1 or Placebo (dose level 2)

Intervention Type DRUG

GX-P1 dose level 2 or placebo

GX-P1 dose level 3

Group Type EXPERIMENTAL

GX-P1 or Placebo (dose level 3)

Intervention Type DRUG

GX-P1 dose level 3 or placebo

Interventions

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GX-P1 or Placebo (dose level 1)

GX-P1 dose level 1 or placebo

Intervention Type DRUG

GX-P1 or Placebo (dose level 2)

GX-P1 dose level 2 or placebo

Intervention Type DRUG

GX-P1 or Placebo (dose level 3)

GX-P1 dose level 3 or placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
2. Healthy male volunteers aged 19-45 years within screening periods
3. Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
4. Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

Exclusion Criteria

1. Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
2. History of or current disease evidence including malignant tumor
3. History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
4. Have participated in another clinical trial with investigational drug within 180 days prior to screening period
5. Positive for HCV antibody, HBsAg, or HIV antibody at screening period
6. Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes