GS3-007a Oral Solution in Healthy Subjects

NCT05611281 | Completed Phase 1

• 1 other identifier: GenSci073-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Adverse events during treatment：Number of participants with treatment-related adverse events as assessed by Guidelines for NIA adverse Events and Serious Adverse Events , To evaluate the safety and tolerability of GS3-007A in single, multiple, and single oral administration after high-fat meals in Chinese healthy adults.

  Part 1:Changes in safety data from baseline 3 days after dosing; Part 2:Changes in safety data from baseline 10 days after dosing; Part 3:Changes in safety data from baseline 6 days after dosing;

Secondary Outcomes (1)

• PK characteristics

  Part 1: Values measured at baseline and within 3 days after dosing; Part 2: Values measured at baseline and within 10days after dosing; Part 3: Values measured at baseline and within 6 days after dosing;

Study Arms (2)

GS3-007 oral liquid

EXPERIMENTAL

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.

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

Placebo GS3-007 oral liquid

PLACEBO COMPARATOR

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

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

Interventions

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

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

GS3-007 oral liquid; Placebo GS3-007 oral liquid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• Patients with a history of substance abuse and substance dependence;
• Family history of sudden death;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Chengdu, 610000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: November 10, 2022
• Study Start: September 22, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 11, 2023

Record last verified: 2022-10

Locations

CN (1)