A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults
ConditionHealthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.
About this trial
This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures;
From screening day to 3 months after the last dose, have no plans for conception or sperm/egg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.).
Disqualifiers
A highly allergic constitution
Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.
Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
Trial design
Design model
Parallel
Treatments tested in this trial
GS3-007a for Suspension
DrugGS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C.
Placebo GS3-007a for Suspension
DrugPlacebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug.
Treatment groups
32 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: GS3-007a- dose level 1 (SAD/FE)Experimental treatment 1 intervention
Group B: GS3-007a- dose level 2 (SAD/FE)Experimental treatment 1 intervention
Group C: Placebo (SAD/FE)Placebo comparator 1 intervention
Group D: GS3-007a- dose level 1 (MAD)Experimental treatment 1 intervention
Group E: GS3-007a- dose level 2 (MAD)Experimental treatment 1 intervention
Group F: Placebo (MAD)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame
up to 6 days (SAD+FE phase), up to 21 days (MAD)Secondary outcomes
1
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax)
Time frame
up to 6 days (SAD+FE phase)2
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax)
Time frame
up to 6 days (SAD+FE phase)3
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Time frame
up to 6 days (SAD+FE phase)4
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)
Time frame
up to 6 days (SAD+FE phase)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov