GS3-007a Oral Solution in Healthy Subjects

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-04-01

Brief Summary

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To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

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Detailed Description

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This is a first-in-human, The major aims of the study are to define the safety profile of this new drug, and to determine a recommended

Conditions

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Healthy Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GS3-007 oral liquid

78 subjects: Part 1 SAD 36 subjects: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.

Part 2 MAD 30 subjects: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days Part 3 Food effects 12 subjects: Planned in 1.6mg/kg dose group。Once a day, a total of one dose.

Group Type EXPERIMENTAL

GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

Intervention Type DRUG

The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Placebo GS3-007 oral liquid

Part 1 SAD: A total of 6 dose groups of 0.4 mg/kg, 0.8 mg/kg, 1.6 mg/kg, 3.2 mg/kg, 4.8 mg/kg and 6.4 mg/kg are planned. Once a day, a total of one dose.

Part 2 MAD: Three dose groups of 0.8 mg/kg, 1.6 mg/kg and 3.2 mg/kg were planned，The drug was administered once a day for 7 days

Group Type PLACEBO_COMPARATOR

GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

Intervention Type DRUG

The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Interventions

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GS3-007 oral liquid or Placebo GS3-007 oral liquid oral medication

The dosage was calculated according to body weight and dose group once a day according to the assigned group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adult subjects aged 18-45 years (including boundary values), male and female;
* Body mass index: 19-26 kg/m2 (including boundary value), male weight ≥50 kg, female weight ≥45 kg;